Life Sciences Training Courses

The pandemic created numerous challenges across all areas of business worldwide and life science companies responded very quickly. Now, as the healthcare sector emerges stronger and with renewed leadership, the industry can continue to focus on key areas for development and explore ways to challenge existing processes, harness collaborations and build resilience.

Our product portfolio has been designed to focus on latest developments and best practice, covering key topics across the pharmaceutical lifecycle, including clinical, regulatory, pharmacovigilance, medical technology, medical writing and biopharma.

  • 21-22 Oct
  • +3

EU Pharmaceutical Regulations & Strategy

Live online
Focused

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations. The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • 26-29 Oct
  • +3

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 18 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • 1-2 Nov
  • +3

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • 1-2 Nov
  • +4

Drug/Device and Device/Drug Combinations in the EU and USA

Live online
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 3 more
  • 2-3 Nov
  • +2

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours
  • Presented by Stuart Angell
  • 2-3 Nov
  • +2

The New EU Animal Health Legislation for Veterinary Medicinal Products

Live online
Focused

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • 10-12 Nov
  • +4

An Introduction to the Medical Device Regulation

Live online
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • 15-17 Nov
  • +2

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • 18-19 Nov
  • +2

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • 18-19 Nov
  • +2

Clinical Quality Management Systems

Live online
Focused

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 22 Nov
  • +3

Regulatory Strategies for Orphan Drugs

Live online
Focused

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

  • 6 CPD hours
  • Presented by Marloes van der Geer
  • 24-25 Nov
  • +2

Pharmaceutical Regulatory Affairs in China

Live online
Focused

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • 24-25 Nov
  • +4

Advanced Veterinary Pharmacovigilance

Live online
Focused

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 24-25 Nov
  • +2

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • 1-2 Dec
  • +4

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 1-2 Dec
  • +1

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours
  • Presented by Ray Munden
  • and Dr Allan Watkinson
  • 1-2 Dec
  • +3

Common Technical Document

Live online
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • 1-3 Dec
  • +4

Advanced Pharmacovigilance

Classroom
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • 1 Dec
  • +4

Effective Technical Writing & Editing

Classroom
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • 1-3 Dec
  • +3

Biotechnology for the Non-Biotechnologist

Classroom
Focused

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

  • 18 CPD hours
  • Presented by Dr Adekunle Onadipe
  • + 6 more
  • 2-3 Dec
  • +1

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

Live online
Focused

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

  • 12 CPD hours
  • Presented by Dr Elinor McCartney
  • and Dr. Kristi Smedley
  • 2 Dec
  • +3

Best Practice for Writing Effective SOPs

Live online
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 3 Dec
  • +3

CAPA (Corrective and Preventative Action)

Live online
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 6-8 Dec
  • +3

Pharmacovigilance

Live online
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 6 more
  • 6-7 Dec
  • +2

Veterinary Pharmaceutical Submissions in the EU

Live online
Focused

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • 8-9 Dec
  • +3

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz
  • 9-10 Dec
  • +2

Dry Powder Inhalers

Classroom
Focused

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design *FULLY UPDATED PROGRAMME*

  • 12 CPD hours
  • Presented by Mr David Howlett
  • + 2 more
  • 10 Dec
  • +2

Borderlines between Medicines and Food

Live online
Focused

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

  • 6 CPD hours
  • Presented by David Richardson
  • + 2 more
  • 13-17 Dec
  • +2

The Medical Device School - From Concept to CE Marking

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours
  • Presented by Ms Janette Benaddi
  • 14-15 Dec
  • +2

Pharmaceutical Packaging, Labelling and Artwork Origination

Live online
Focused

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

  • 12 CPD hours
  • Presented by Mr Christopher Waterhouse
  • + 6 more
  • 15-16 Dec
  • +2

Pharmaceutical Regulatory Affairs in the Middle East

Live online
Focused

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz
  • 10-11 Jan 2022-
  • +3

EU Clinical Trial Regulation: Overview and Implementation

Classroom
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 11-12 Jan 2022-
  • +3

Effective Technology Transfer

Classroom
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • 11-12 Jan 2022-
  • +3

Biosimilars

Classroom
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours
  • Presented by Marloes van der Geer
  • 13 Jan 2022-
  • +3

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 17-18 Jan 2022-
  • +3

Managing Vendor/CRO/CMO Oversight

Classroom
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 18 Jan 2022-
  • +3

Filing eCTD Submissions

Classroom
Focused

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

  • 6 CPD hours
  • Presented by Maikel Bouman
  • and Marloes van der Geer
  • 20 Jan 2022-
  • +3

A Practical Guide to Producing and Maintaining the PSMF

Live online
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 27-28 Jan 2022-
  • +1

Clinical Trial Regulatory Requirements

Live online
Focused

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 1-2 Feb 2022-
  • +3

Common Technical Document

Classroom
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours
  • 1-2 Feb 2022-
  • +4

Advanced Veterinary Pharmacovigilance

Classroom
Focused

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 1-2 Feb 2022-
  • +4

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Classroom
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 3-4 Feb 2022-
  • +1

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online
Focused

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • 8-10 Feb 2022-
  • +4

An Introduction to the Medical Device Regulation

Classroom
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • 8-9 Feb 2022-
  • +1

Biological Evaluation of Medical Devices

Classroom
Focused

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions

  • 12 CPD hours
  • Presented by Mr Philip Clay
  • and Janine Ingleby
  • 9 Feb 2022-
  • +4

Effective Technical Writing & Editing

Live online
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • 22-23 Feb 2022-
  • +3

Signal Detection and Regulatory Expectations

Classroom
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • 22-23 Feb 2022-
  • +2

Development of Combination Products: Critical Interactions

Classroom
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • 1-3 Mar 2022-
  • +4

Advanced Pharmacovigilance

Live online
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • 1-2 Mar 2022-
  • +1

Advanced Regulatory Affairs for Medical Devices

Live online
Focused

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • and Ms Theresa Jeary
  • 1 Mar 2022-
  • +1

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online
Focused

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 7-9 Mar 2022-
  • +3

Biotechnology for the Non-Biotechnologist

Live online
Focused

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

  • 18 CPD hours
  • Presented by Dr Adekunle Onadipe
  • + 6 more
  • 8-9 Mar 2022-
  • +2

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Live online
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours
  • Presented by Mr Richard Featherstone
  • 9-10 Mar 2022-
  • +2

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 10 Mar 2022-
  • +2

GCP and Clinical Research Update - Hot Inspection Topics

Live online
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 10-11 Mar 2022-
  • +4

Drug/Device and Device/Drug Combinations in the EU and USA

Live online
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • 14-15 Mar 2022-
  • +2

Process Validation with Qualification

Live online
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • 16 Mar 2022-
  • +3

Regulatory Strategies for Orphan Drugs

Live online
Focused

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

  • 6 CPD hours
  • Presented by Marloes van der Geer
  • 17-18 Mar 2022-
  • +1

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

Live online
Focused

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

  • 12 CPD hours
  • Presented by Dr Mel Munro
  • and Dr Tamsin Dawson
  • 21-22 Mar 2022-
  • +2

The FDA Drug Approval Process

Live online
Focused

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

  • 12 CPD hours
  • 28-29 Mar 2022-
  • +2

An Introduction to Pharmaceutical Packaging

Live online
Focused

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours
  • Presented by Mr Chris Penfold
  • 28-29 Mar 2022-
  • +2

Regulatory Affairs for Support Staff

Live online
Focused

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • 29-30 Mar 2022-
  • +3

FDA Approval Process for Medical Devices

Live online
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • 30-31 Mar 2022-
  • +1

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

  • 12 CPD hours
  • Presented by Andreas Rothmund
  • + 2 more
  • 30 Mar 2022-
  • +1

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

  • 6 CPD hours
  • Presented by Dr John Price
  • 31 Mar-1 Apr 2022-
  • +2

Metered Dose Inhaler (MDI) Technology

Live online
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

  • 12 CPD hours
  • Presented by Mr David Howlett
  • 4-5 Apr 2022-
  • +3

Biosimilars

Live online
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours
  • Presented by Marloes van der Geer
  • 4 Apr 2022-
  • +3

A Practical Guide to Writing Risk Management Plans (RMPs)

Classroom
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 5 Apr 2022-
  • +2

Data Integrity and Document Management

Live online
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 5-6 Apr 2022-
  • +2

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours
  • Presented by Mr David Howlett
  • 5 Apr 2022-
  • +3

A Practical Guide to Producing and Maintaining the PSMF

Classroom
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 6-7 Apr 2022-
  • +2

Medical Writing for Medical Devices

Live online
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • 6-7 Apr 2022-
  • +3

Effective Technology Transfer

Live online
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • 7-8 Apr 2022-
  • +3

EU Clinical Trial Regulation: Overview and Implementation

Live online
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 8 Apr 2022-
  • +1

An Essential Overview of Pharmacovigilance

Live online
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 11-12 Apr 2022-
  • +3

EU Pharmaceutical Regulations & Strategy

Live online
Focused

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations. The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • 11-12 Apr 2022-
  • +3

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 12-13 Apr 2022-
  • +2

New Medical Device Regulation

Live online
Focused

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • 12-13 Apr 2022-
  • +2

Medical Device Regulation in the Eurasion Union, Russia and the CIS

Live online
Focused

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • 20-22 Apr 2022-
  • +2

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • 25-26 Apr 2022-
  • +2

Pharmaceutical Development of ATMPs

Live online
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • 25 Apr 2022-
  • +3

Filing eCTD Submissions

Live online
Focused

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

  • 6 CPD hours
  • Presented by Maikel Bouman
  • and Marloes van der Geer
  • 25 Apr 2022-
  • +2

Pharmacovigilance Aspects of Licensing Agreements

Live online
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • and Joanne Flitcroft
  • 25-28 Apr 2022-
  • +3

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 18 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • 26-27 Apr 2022-
  • +2

Introduction to Veterinary Pharmacovigilance

Live online
Focused

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 26-27 Apr 2022-
  • +1

Variations to Marketing Authorisations

Live online
Focused

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

  • 12 CPD hours
  • Presented by Marloes van der Geer
  • 26-27 Apr 2022-
  • +1

Nasal Drug Delivery

Live online
Focused

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

  • 12 CPD hours
  • Presented by PhD Anders Fuglsang
  • + 12 more
  • 27-29 Apr 2022-
  • +2

Successful Medical Writing

Live online
Focused

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

  • 18 CPD hours
  • Presented by Ms Barbara Grossman
  • + 2 more
  • 28-29 Apr 2022-
  • +2

Practical Implementation of GCP in Veterinary Field Studies

Live online
Focused

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • and Ms Marie-Pascale Tiberghien
  • 29 Apr 2022-
  • +1

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 4-5 May 2022-
  • +4

Advanced Veterinary Pharmacovigilance

Live online
Focused

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 4-5 May 2022-
  • +4

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 5-6 May 2022-
  • +2

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • 5-6 May 2022-
  • +3

Common Technical Document

Live online
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours
  • 9-10 May 2022-
  • +2

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 16-17 May 2022-
  • +3

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • 16-17 May 2022-
  • +2

The New EU Animal Health Legislation for Veterinary Medicinal Products

Live online
Focused

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • 18-20 May 2022-
  • +4

An Introduction to the Medical Device Regulation

Live online
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • 19-20 May 2022-
  • +2

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • 23 May 2022-
  • +1

An Essential Overview of the Medical Device Industry

Live online
Focused

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • 23-24 May 2022-
  • +2

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • 25-26 May 2022-
  • +1

Technical Documentation to Comply with the MDR and IVDR

Live online
Focused

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

  • 12 CPD hours
  • Presented by Paul Sim
  • and Mr Will Burton
  • 25-26 May 2022-
  • +2

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • 25-26 May 2022-
  • +2

Pharmaceutical Regulatory Affairs in China

Live online
Focused

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • 26-27 May 2022-
  • +2

Clinical Quality Management Systems

Live online
Focused

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 7-8 Jun 2022-
  • +2

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Classroom
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 7-8 Jun 2022-
  • +4

Drug/Device and Device/Drug Combinations in the EU and USA

Classroom
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • 7-9 Jun 2022-
  • +4

Advanced Pharmacovigilance

Classroom
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • 9-10 Jun 2022-
  • +2

Veterinary Pharmaceutical Submissions in the EU

Live online
Focused

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • 13-14 Jun 2022-
  • +2

An Introduction to Pharmaceutical Packaging

Live online
Focused

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours
  • Presented by Mr Chris Penfold
  • 13-17 Jun 2022-
  • +2

The Medical Device School - From Concept to CE Marking

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours
  • Presented by Ms Janette Benaddi
  • 15-16 Jun 2022-
  • +3

FDA Approval Process for Medical Devices

Classroom
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • 15-16 Jun 2022-
  • +3

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz
  • 15 Jun 2022-
  • +4

Effective Technical Writing & Editing

Classroom
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • 16 Jun 2022-
  • +2

GCP and Clinical Research Update - Hot Inspection Topics

Classroom
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 16 Jun 2022-
  • +2

Borderlines between Medicines and Food

Live online
Focused

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

  • 6 CPD hours
  • Presented by David Richardson
  • + 2 more
  • 20-21 Jun 2022-
  • +2

The FDA Drug Approval Process

Classroom
Focused

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

  • 12 CPD hours
  • 20-21 Jun 2022-
  • +2

Process Validation with Qualification

Classroom
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • 20-21 Jun 2022-

Registration of Animal Feed Additives in the EU

Live online
Focused

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

  • 12 CPD hours
  • Presented by Dr Elinor McCartney
  • 20-24 Jun 2022-
  • +1

Working Through Veterinary Drug Development in the EU and USA

Live online
Intensive

This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

  • 24 CPD hours
  • Presented by David Petrick
  • and Dr Julian Braidwood
  • 20-21 Jun 2022-
  • +2

Metered Dose Inhaler (MDI) Technology

Classroom
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

  • 12 CPD hours
  • Presented by Mr David Howlett
  • 21-23 Jun 2022-
  • +3

Pharmacovigilance

Live online
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 6 more
  • 27 Jun 2022-
  • +3

Regulatory Strategies for Orphan Drugs

Classroom
Focused

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

  • 6 CPD hours
  • Presented by Marloes van der Geer
  • 27 Jun 2022-
  • +3

Best Practice for Writing Effective SOPs

Live online
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 27-29 Jun 2022-
  • +3

Biotechnology for the Non-Biotechnologist

Classroom
Focused

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

  • 18 CPD hours
  • Presented by Dr Adekunle Onadipe
  • + 6 more
  • 27-28 Jun 2022-
  • +2

Pharmaceutical Packaging, Labelling and Artwork Origination

Classroom
Focused

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

  • 12 CPD hours
  • Presented by Mr Christopher Waterhouse
  • + 6 more
  • 27-28 Jun 2022-
  • +2

Regulatory Affairs for Support Staff

Classroom
Focused

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • 28 Jun 2022-
  • +3

CAPA (Corrective and Preventative Action)

Live online
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 28-29 Jun 2022-
  • +2

Dry Powder Inhalers

Live online
Focused

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design *FULLY UPDATED PROGRAMME*

  • 12 CPD hours
  • Presented by Mr David Howlett
  • + 2 more
  • 29-30 Jun 2022-
  • +2

Pharmaceutical Regulatory Affairs in the Middle East

Live online
Focused

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz
  • 30 Jun-1 Jul 2022-
  • +2

Practical Implementation of GCP in Veterinary Field Studies

Classroom
Focused

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • and Ms Marie-Pascale Tiberghien
  • 4-7 Jul 2022-
  • +3

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Classroom
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 18 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • 4-5 Jul 2022-
  • +3

Biosimilars

Classroom
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours
  • Presented by Marloes van der Geer
  • 4-5 Jul 2022-
  • +2

An Introduction to the Design and Development of Medical Devices

Classroom
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours
  • Presented by Mr David Howlett
  • 4-5 Jul 2022-
  • +3

Effective Technology Transfer

Classroom
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • 4-5 Jul 2022-
  • +3

EU Clinical Trial Regulation: Overview and Implementation

Classroom
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 5-6 Jul 2022-
  • +2

Medical Device Regulation in the Eurasion Union, Russia and the CIS

Classroom
Focused

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • 5-6 Jul 2022-
  • +2

Introduction to Veterinary Pharmacovigilance

Classroom
Focused

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 5-6 Jul 2022-
  • +2

Medical Writing for Medical Devices

Classroom
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • 5-6 Jul 2022-
  • +3

EU Pharmaceutical Regulations & Strategy

Classroom
Focused

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations. The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • 7 Jul 2022-
  • +2

Data Integrity and Document Management

Classroom
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 11-12 Jul 2022-
  • +2

New Medical Device Regulation

Classroom
Focused

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • 11 Jul 2022-
  • +3

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 11 Jul 2022-
  • +3

Filing eCTD Submissions

Classroom
Focused

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

  • 6 CPD hours
  • Presented by Maikel Bouman
  • and Marloes van der Geer
  • 11-12 Jul 2022-
  • +3

Managing Vendor/CRO/CMO Oversight

Classroom
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 11-13 Jul 2022-
  • +2

Successful Medical Writing

Classroom
Focused

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

  • 18 CPD hours
  • Presented by Ms Barbara Grossman
  • + 2 more
  • 12 Jul 2022-
  • +3

A Practical Guide to Producing and Maintaining the PSMF

Live online
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 13 Jul 2022-
  • +2

Pharmacovigilance Aspects of Licensing Agreements

Classroom
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • and Joanne Flitcroft
  • 13-14 Jul 2022-
  • +2

Pharmaceutical Development of ATMPs

Classroom
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • 14-15 Jul 2022-
  • +1

Clinical Trial Regulatory Requirements

Live online
Focused

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 14-15 Jul 2022-
  • +1

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours
  • Presented by Ray Munden
  • and Dr Allan Watkinson
  • 1-2 Aug 2022-
  • +4

Advanced Veterinary Pharmacovigilance

Classroom
Focused

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 1-3 Aug 2022-
  • +4

An Introduction to the Medical Device Regulation

Classroom
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • 1-2 Aug 2022-
  • +1

Biological Evaluation of Medical Devices

Classroom
Focused

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions

  • 12 CPD hours
  • Presented by Mr Philip Clay
  • and Janine Ingleby
  • 8-9 Aug 2022-
  • +4

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Classroom
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 15-16 Aug 2022-
  • +2

Medical Device Studies: Clinical Evidence

Classroom
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 15-16 Aug 2022-
  • +1

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online
Focused

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • 6-7 Sep 2022-
  • +1

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

Live online
Focused

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

  • 12 CPD hours
  • Presented by Dr Mel Munro
  • and Dr Tamsin Dawson
  • 8 Sep 2022-
  • +1

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

  • 6 CPD hours
  • Presented by Dr John Price
  • 12-13 Sep 2022-
  • +3

FDA Approval Process for Medical Devices

Live online
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • 13-14 Sep 2022-
  • +2

Metered Dose Inhaler (MDI) Technology

Live online
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

  • 12 CPD hours
  • Presented by Mr David Howlett
  • 14-15 Sep 2022-
  • +2

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Live online
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours
  • Presented by Mr Richard Featherstone
  • 16 Sep 2022-
  • +1

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online
Focused

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 19-20 Sep 2022-
  • +2

The FDA Drug Approval Process

Live online
Focused

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

  • 12 CPD hours
  • 19-20 Sep 2022-
  • +2

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 19 Sep 2022-
  • +3

Best Practice for Writing Effective SOPs

Classroom
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 20-22 Sep 2022-
  • +3

Pharmacovigilance

Classroom
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 6 more
  • 20 Sep 2022-
  • +3

CAPA (Corrective and Preventative Action)

Classroom
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 20-21 Sep 2022-
  • +3

Medical Device Regulations in the Middle East and North Africa

Classroom
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz
  • 21-23 Sep 2022-
  • +4

Advanced Pharmacovigilance

Live online
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • 21-22 Sep 2022-
  • +1

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

  • 12 CPD hours
  • Presented by Andreas Rothmund
  • + 2 more
  • 22 Sep 2022-
  • +2

GCP and Clinical Research Update - Hot Inspection Topics

Live online
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 26-27 Sep 2022-
  • +2

Process Validation with Qualification

Live online
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • 26 Sep 2022-
  • +3

Regulatory Strategies for Orphan Drugs

Live online
Focused

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

  • 6 CPD hours
  • Presented by Marloes van der Geer
  • 27-28 Sep 2022-
  • +2

Regulatory Affairs for Support Staff

Live online
Focused

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • 27-28 Sep 2022-
  • +1

Advanced Regulatory Affairs for Medical Devices

Live online
Focused

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • and Ms Theresa Jeary
  • 28-30 Sep 2022-
  • +3

Biotechnology for the Non-Biotechnologist

Live online
Focused

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

  • 18 CPD hours
  • Presented by Dr Adekunle Onadipe
  • + 6 more
  • 28-29 Sep 2022-
  • +2

An Introduction to Pharmaceutical Packaging

Live online
Focused

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours
  • Presented by Mr Chris Penfold
  • 29-30 Sep 2022-
  • +4

Drug/Device and Device/Drug Combinations in the EU and USA

Live online
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • 30 Sep 2022-
  • +4

Effective Technical Writing & Editing

Live online
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • 3 Oct 2022-
  • +3

A Practical Guide to Writing Risk Management Plans (RMPs)

Classroom
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 4-5 Oct 2022-
  • +1

Nasal Drug Delivery

Classroom
Focused

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

  • 12 CPD hours
  • Presented by PhD Anders Fuglsang
  • + 12 more
  • 4-5 Oct 2022-
  • +2

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours
  • Presented by Mr David Howlett
  • 4-7 Oct 2022-
  • +3

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 18 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • 4 Oct 2022-
  • +3

A Practical Guide to Producing and Maintaining the PSMF

Classroom
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 6-7 Oct 2022-
  • +2

Pharmaceutical Development of ATMPs

Live online
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • 10 Oct 2022-
  • +2

Data Integrity and Document Management

Live online
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 10 Oct 2022-
  • +1

An Essential Overview of Pharmacovigilance

Live online
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • 11-13 Oct 2022-
  • +2

Successful Medical Writing

Live online
Focused

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

  • 18 CPD hours
  • Presented by Ms Barbara Grossman
  • + 2 more
  • 11-12 Oct 2022-
  • +3

Biosimilars

Live online
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours
  • Presented by Marloes van der Geer
  • 11-12 Oct 2022-
  • +3

Effective Technology Transfer

Live online
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • 12-13 Oct 2022-
  • +2

Medical Device Regulation in the Eurasion Union, Russia and the CIS

Live online
Focused

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • 12-14 Oct 2022-
  • +2

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • 13-14 Oct 2022-
  • +1

Variations to Marketing Authorisations

Live online
Focused

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

  • 12 CPD hours
  • Presented by Marloes van der Geer
  • 13-14 Oct 2022-
  • +2

New Medical Device Regulation

Live online
Focused

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • 14 Oct 2022-
  • +1

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 17-18 Oct 2022-
  • +3

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 17 Oct 2022-
  • +2

Pharmacovigilance Aspects of Licensing Agreements

Live online
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • and Joanne Flitcroft
  • 18-19 Oct 2022-
  • +2

Introduction to Veterinary Pharmacovigilance

Live online
Focused

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 18-19 Oct 2022-
  • +3

EU Pharmaceutical Regulations & Strategy

Live online
Focused

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations. The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • 19 Oct 2022-
  • +3

Filing eCTD Submissions

Live online
Focused

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

  • 6 CPD hours
  • Presented by Maikel Bouman
  • and Marloes van der Geer
  • 19-20 Oct 2022-
  • +2

Medical Writing for Medical Devices

Live online
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • 20-21 Oct 2022-
  • +3

EU Clinical Trial Regulation: Overview and Implementation

Live online
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 20-21 Oct 2022-
  • +2

Practical Implementation of GCP in Veterinary Field Studies

Live online
Focused

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • and Ms Marie-Pascale Tiberghien
  • 2 Nov 2022-
  • +1

An Essential Overview of the Medical Device Industry

Live online
Focused

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • 3-4 Nov 2022-
  • +2

The New EU Animal Health Legislation for Veterinary Medicinal Products

Live online
Focused

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • 3-4 Nov 2022-
  • +2

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • 7-8 Nov 2022-
  • +2

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • 8-10 Nov 2022-
  • +4

An Introduction to the Medical Device Regulation

Live online
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • 14-15 Nov 2022-
  • +2

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 16-17 Nov 2022-
  • +2

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • 17-18 Nov 2022-
  • +2

Clinical Quality Management Systems

Live online
Focused

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • 21-22 Nov 2022-
  • +4

Advanced Veterinary Pharmacovigilance

Live online
Focused

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • 22-23 Nov 2022-
  • +1

Technical Documentation to Comply with the MDR and IVDR

Live online
Focused

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

  • 12 CPD hours
  • Presented by Paul Sim
  • and Mr Will Burton
  • 22-23 Nov 2022-
  • +2

Pharmaceutical Regulatory Affairs in China

Live online
Focused

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • 23-24 Nov 2022-
  • +2

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • 28-29 Nov 2022-
  • +3

Common Technical Document

Live online
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours
  • 28-29 Nov 2022-
  • +4

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 29-30 Nov 2022-
  • +3

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • 1 Dec 2022-
  • +2

Borderlines between Medicines and Food

Live online
Focused

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

  • 6 CPD hours
  • Presented by David Richardson
  • + 2 more
  • 5-9 Dec 2022-
  • +2

The Medical Device School - From Concept to CE Marking

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours
  • Presented by Ms Janette Benaddi
  • 5-9 Dec 2022-
  • +1

Working Through Veterinary Drug Development in the EU and USA

Live online
Intensive

This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

  • 24 CPD hours
  • Presented by David Petrick
  • and Dr Julian Braidwood
  • 6-7 Dec 2022-
  • +1

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

Live online
Focused

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

  • 12 CPD hours
  • Presented by Dr Elinor McCartney
  • 7-8 Dec 2022-
  • +2

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Classroom
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours
  • Presented by Mr Richard Featherstone
  • 7-8 Dec 2022-
  • +3

FDA Approval Process for Medical Devices

Classroom
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • 7-9 Dec 2022-
  • +4

Advanced Pharmacovigilance

Classroom
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • 7-8 Dec 2022-
  • +3

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz
  • 12 Dec 2022-
  • +3

Best Practice for Writing Effective SOPs

Live online
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 12-13 Dec 2022-
  • +2

Pharmaceutical Packaging, Labelling and Artwork Origination

Live online
Focused

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

  • 12 CPD hours
  • Presented by Mr Christopher Waterhouse
  • + 6 more
  • 13-14 Dec 2022-
  • +2

Veterinary Pharmaceutical Submissions in the EU

Live online
Focused

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • 13 Dec 2022-
  • +3

CAPA (Corrective and Preventative Action)

Live online
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • 14-15 Dec 2022-
  • +2

Dry Powder Inhalers

Classroom
Focused

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design *FULLY UPDATED PROGRAMME*

  • 12 CPD hours
  • Presented by Mr David Howlett
  • + 2 more
  • 14-15 Dec 2022-
  • +4

Drug/Device and Device/Drug Combinations in the EU and USA

Classroom
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • 14 Dec 2022-
  • +4

Effective Technical Writing & Editing

Classroom
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • 14-16 Dec 2022-
  • +3

Pharmacovigilance

Live online
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 6 more
  • 14-15 Dec 2022-
  • +2

Pharmaceutical Regulatory Affairs in the Middle East

Live online
Focused

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz