Scheduled In-house

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.

  • Next: 13-16 Mar 2023 Live online
  • Also: 10-11 Jul 2023 Classroom
  • Also: 13-14 Nov 2023 Live online

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

Live online, Classroom
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
  • Next: 20 Jan 2023 Live online
  • Also: 27-28 Apr 2023 Live online
  • Also: 25 Jul 2023 Live online
  • Also: 3 Oct 2023 Classroom

A Practical Guide to Producing and Maintaining the PSMF

Live online, 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
  • Next: 19 Jan 2023 Live online
  • Also: 20-21 Apr 2023 Live online
  • Also: 24 Jul 2023 Live online
  • Also: 2 Oct 2023 Classroom

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online, 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
  • Next: 1-2 Dec 2022 Live online

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

  • 12 CPD hours
  • Presented by Dawn Botha
  • + 3 more
  • Next: 7-9 Dec 2022 Classroom
  • Also: 29-31 Mar 2023 Live online
  • Also: 7-9 Jun 2023 Classroom
  • + 2 more

Advanced Pharmacovigilance

Live online, 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
  • Next: 2-3 Feb 2023 Live online
  • Also: 6-9 Jun 2023 Live online
  • Also: 9-10 Oct 2023 Classroom

Advanced Regulatory Affairs for Medical Devices

Live online, Classroom
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
  • Next: 21-22 Nov 2022 Live online
  • Also: 23-26 Jan 2023 Live online
  • Also: 18-19 Apr 2023 Live online
  • + 2 more

Advanced Veterinary Pharmacovigilance

Live online, 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
  • Next: 1 Dec 2022 Live online
  • Also: 1 Jun 2023 Classroom
  • Also: 1 Dec 2023 Live online

An Essential Overview of Medical Information

Live online, Classroom
Focused

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 31 Jan 2023 Live online
  • Also: 18 May 2023 Classroom
  • Also: 11-12 Sep 2023 Live online

An Essential Overview of Pharmacovigilance

Live online, Classroom
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 2 Dec 2022 Live online
  • Also: 29 Mar 2023 Live online
  • Also: 10-11 Jul 2023 Live online
  • Also: 10 Nov 2023 Live online

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
  • Next: 20 Jan 2023 Live online
  • Also: 12 May 2023 Live online
  • Also: 15 Sep 2023 Live online

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
  • Next: 31 Jan-3 Feb 2023 Live online
  • Also: 23-24 May 2023 Live online
  • Also: 27-28 Sep 2023 Live online

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
  • Next: 13 Dec 2022 Classroom
  • Also: 27 Mar 2023 Live online
  • Also: 14 Jun 2023 Classroom
  • + 2 more

An Introduction to Quality Management for Managers

New for 2022

Live online, Classroom
Focused

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 4-5 Oct 2022 Live online
  • Also: 24-27 Apr 2023 Live online
  • Also: 3-4 Jul 2023 Classroom
  • Also: 5-6 Oct 2023 Live online

An Introduction to the Design and Development of Medical Devices

Live online, 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
  • Next: 8-10 Nov 2022 Live online
  • Also: 7-9 Feb 2023 Live online
  • Also: 17-19 May 2023 Live online
  • + 2 more

An Introduction to the Medical Device Regulation

Live online, 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
  • Next: 12 Dec 2022 Live online
  • Also: 28 Apr 2023 Live online
  • Also: 17 Jul 2023 Live online
  • Also: 14 Dec 2023 Live online

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
  • Next: 23-24 Mar 2023 Classroom
  • Also: 18-19 Sep 2023 Classroom

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 Rona Middlemiss
  • Next: 11-12 Oct 2022 Live online

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 Hans van Bruggen
  • and Marloes van der Geer
  • Next: 5-9 Dec 2022 Live online

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
  • Next: 1 Dec 2022 Live online
  • Also: 26-27 Apr 2023 Live online
  • Also: 14 Jul 2023 Live online
  • Also: 1 Dec 2023 Live online

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 Mr Brian Kelly
  • and Ms Penny Viner
  • Next: 13 Dec 2022 Live online
  • Also: 27 Apr 2023 Live online
  • Also: 18 Jul 2023 Live online
  • Also: 15 Dec 2023 Live online

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
  • Next: 2-3 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Classroom
  • Also: 26-27 Oct 2023 Live online

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2023

Live online, Classroom
Focused

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 28-29 Nov 2022 Live online
  • Also: 27 Feb-2 Mar 2023 Live online
  • Also: 4-5 May 2023 Live online
  • + 2 more

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online, 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
  • Next: 5-6 Oct 2022 Live online
  • Also: 8-9 Feb 2023 Live online
  • Also: 21-22 Jun 2023 Live online
  • Also: 4-5 Oct 2023 Live online

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
  • Next: 17-18 Nov 2022 Live online
  • Also: 16-17 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Classroom
  • Also: 16-17 Nov 2023 Live online

Clinical Quality Management Systems

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 2-3 Feb 2023 Live online
  • Also: 5-6 Jun 2023 Live online
  • Also: 9-10 Oct 2023 Live online

Clinical Trial Monitoring

New for 2023

Live online

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 23-24 Jan 2023 Live online
  • Also: 25-26 May 2023 Classroom
  • Also: 21-22 Sep 2023 Live online

Clinical Trial Regulatory Requirements

Live online, Classroom
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 key difference it compares with the Clinical Directive requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 11 Oct 2022 Live online
  • Also: 20 Jan 2023 Live online
  • Also: 28 Apr 2023 Live online
  • + 2 more

Cyber Security for Medical Devices

Live online, Classroom
Focused

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

  • 6 CPD hours
  • Presented by Mr Ben Kokx
  • Next: 10 Oct 2022 Live online
  • Also: 21 Apr 2023 Live online
  • Also: 24 Jul 2023 Classroom
  • Also: 1 Dec 2023 Live online

Data Integrity and Document Management

Live online, 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
  • Next: 7-8 Nov 2022 Live online
  • Also: 20-21 Feb 2023 Live online
  • Also: 27-28 Jun 2023 Classroom
  • Also: 9-12 Oct 2023 Live online

Development of Combination Products: Critical Interactions

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 7 Nov 2022 Live online
  • Also: 10 Nov 2022 Live online
  • Also: 14-15 Dec 2022 Classroom

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

Live online, Classroom
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 3 more
  • Next: 14 Dec 2022 Classroom
  • Also: 1-2 Feb 2023 Live online
  • Also: 14 Jun 2023 Classroom
  • Also: 20 Oct 2023 Live online

Effective Technical Writing & Editing

Live online, 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
  • Next: 11-12 Oct 2022 Live online
  • Also: 24-25 Jan 2023 Live online
  • Also: 19-20 Apr 2023 Live online
  • + 2 more

Effective Technology Transfer

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 8 Nov 2022 Live online
  • Also: 1 Mar 2023 Live online
  • Also: 7 Jul 2023 Live online
  • Also: 9 Nov 2023 Live online

EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers

New for 2022

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

  • 3 CPD hours
  • Presented by Mr Koen Cobbaert
  • Next: 20-21 Feb 2023 Live online
  • Also: 22-23 May 2023 Live online
  • Also: 13-14 Jul 2023 Classroom
  • Also: 13-14 Nov 2023 Live online

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 18-19 Oct 2022 Live online
  • Also: 20-23 Feb 2023 Live online
  • Also: 13-14 Jun 2023 Classroom
  • Also: 16-17 Oct 2023 Live online

EU Pharmaceutical Regulations & Strategy

Live online, Classroom
Focused

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 2-4 Nov 2022 Live online
  • Also: 6-10 Mar 2023 Live online
  • Also: 27-29 Jun 2023 Classroom
  • Also: 6-10 Nov 2023 Live online

European Post Marketing Pharmacovigilance

New for 2022

Live online, Classroom
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

  • Presented by Dr Graeme Ladds
  • Next: 5-6 Dec 2022 Classroom
  • Also: 21-24 Mar 2023 Live online
  • Also: 21-22 Jun 2023 Live online
  • + 2 more

FDA Approval Process for Medical Devices

Live online, 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
  • Next: on request

Filing eCTD Submissions

Bespoke
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 Jasbir Chohan
  • and Justin Bailey
  • Next: 10 Mar 2023 Live online
  • Also: 20 Jul 2023 Classroom
  • Also: 24 Nov 2023 Live online

GCP and Clinical Research Update - Hot Inspection Topics

Live online, 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
  • Next: 18-19 Jan 2023 Live online
  • Also: 19-20 Apr 2023 Live online
  • Also: 29-30 Jun 2023 Classroom
  • Also: 17-20 Oct 2023 Live online

GMP Fundamentals

New for 2023

Live online, Classroom
Focused

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

  • Presented by Rob Hughes
  • Next: 7-8 Dec 2022 Classroom
  • Also: 7-8 Mar 2023 Classroom
  • Also: 17-20 Jul 2023 Live online
  • Also: 28-29 Nov 2023 Live online

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

Live online, 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
  • Next: 3-4 Nov 2022 Live online
  • Also: 9-10 Mar 2023 Live online
  • Also: 26-27 Jul 2023 Classroom
  • Also: 7-10 Nov 2023 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online, Classroom
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
  • Next: 18-19 Oct 2022 Live online
  • Also: 6-9 Feb 2023 Live online
  • Also: 29-30 Jun 2023 Classroom
  • Also: 4-5 Oct 2023 Live online

Introduction to Veterinary Pharmacovigilance

Live online, 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
  • Next: 17-18 Oct 2022 Live online
  • Also: 16-17 Jan 2023 Live online
  • Also: 17-18 Apr 2023 Live online
  • + 2 more

Managing Vendor/CRO/CMO Oversight

Live online, Classroom
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 18-21 Apr 2023 Live online
  • Also: 4-5 Jul 2023 Classroom
  • Also: 11-12 Dec 2023 Live online

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

Live online, 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
  • Next: 7-8 Dec 2022 Live online
  • Also: 6-7 Feb 2023 Live online
  • Also: 13-14 Jun 2023 Classroom
  • Also: 2-5 Oct 2023 Live online

Medical Device Regulations in the Middle East and North Africa

Live online, 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 Ilona Putz
  • and Ms Heba Hashem
  • Next: 1-2 Dec 2022 Classroom
  • Also: 23-24 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Live online
  • Also: 30 Nov-1 Dec 2023 Classroom

Medical Device Single Audit Programme (MDSAP)

New for 2022

Live online, Classroom
Focused

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 18-21 Oct 2022 Live online
  • Also: 24-27 Apr 2023 Live online
  • Also: 3-6 Jul 2023 Classroom
  • Also: 11-14 Dec 2023 Live online

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

Live online, Classroom
Focused

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

  • 24 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 24-25 Nov 2022 Live online
  • Also: 20-23 Mar 2023 Live online
  • Also: 12-13 Jul 2023 Classroom
  • Also: 13-14 Nov 2023 Live online

Medical Device Studies: Clinical Evidence

Live online, 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
  • Next: 3-4 Oct 2022 Live online
  • Also: 18-19 Jan 2023 Live online
  • Also: 9-10 May 2023 Classroom
  • Also: 18-21 Sep 2023 Live online

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online, 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
  • Next: 19-20 Oct 2022 Live online
  • Also: 15-16 Mar 2023 Live online
  • Also: 4-5 Jul 2023 Classroom
  • Also: 23-24 Nov 2023 Live online

Medical Writing for Medical Devices

Live online, 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
  • Next: 27-30 Mar 2023 Live online
  • Also: 22-23 Jun 2023 Classroom
  • Also: 13-14 Sep 2023 Live online

Metered Dose Inhaler (MDI) Technology

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 21-24 Feb 2023 Live online
  • Also: 29-30 Jun 2023 Classroom
  • Also: 2-3 Oct 2023 Live online

New Regulations for Medical Devices and IVDs in Europe

Live online, Classroom
Focused

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • Next: 6-7 Oct 2022 Live online
  • Also: 6-9 Feb 2023 Live online
  • Also: 20-21 Jun 2023 Classroom
  • Also: 16-17 Oct 2023 Live online

Pharmaceutical Development of ATMPs

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 12-13 Dec 2022 Live online

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
  • Next: 23-24 Nov 2022 Live online
  • Also: 2-3 Mar 2023 Live online
  • Also: 25-26 Jul 2023 Live online
  • Also: 21-24 Nov 2023 Live online

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
  • Next: 8-10 Nov 2022 Live online
  • Also: 22-24 Feb 2023 Live online
  • Also: 14-16 Jun 2023 Classroom
  • Also: 11-13 Oct 2023 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online, Classroom
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
  • Next: 22-23 Nov 2022 Live online
  • Also: 17-18 Apr 2023 Live online
  • Also: 13-14 Jul 2023 Classroom
  • Also: 12-13 Dec 2023 Live online

Pharmaceutical Regulatory Affairs in China

Live online, Classroom
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
  • Next: 16-17 Nov 2022 Live online
  • Also: 9-10 Feb 2023 Live online
  • Also: 26-29 Jun 2023 Live online
  • Also: 5-6 Oct 2023 Classroom

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online, Classroom
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
  • Next: 14-15 Dec 2022 Live online
  • Also: 24-25 Apr 2023 Live online
  • Also: 19-20 Jul 2023 Classroom
  • Also: 11-14 Dec 2023 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online, Classroom
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 Ilona Putz
  • and Ms Heba Hashem
  • Next: 14-16 Dec 2022 Live online
  • Also: 1-3 Feb 2023 Live online
  • Also: 14-16 Jun 2023 Classroom
  • Also: 11-13 Oct 2023 Live online

Pharmacovigilance

Live online, 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
  • + 4 more
  • Next: 17 Mar 2023 Live online
  • Also: 12 Jul 2023 Classroom
  • Also: 29-30 Nov 2023 Live online

Pharmacovigilance Aspects of Licensing Agreements

Live online, 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 Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 21-23 Nov 2022 Live online
  • Also: 22-24 Mar 2023 Live online
  • Also: 3-5 May 2023 Classroom
  • Also: 2-4 Oct 2023 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors

New for 2022

Live online, Classroom
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 16-17 Nov 2022 Live online
  • Also: 23-26 Jan 2023 Live online
  • Also: 22-23 May 2023 Live online
  • Also: 28-29 Sep 2023 Live online

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
  • Next: 29-30 Nov 2022 Live online
  • Also: 2-3 Mar 2023 Live online
  • Also: 17-18 Jul 2023 Classroom
  • Also: 27-30 Nov 2023 Live online

Practical Implementation of GCP in Veterinary Field Studies

Live online, 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 Donna Taylor
  • + 2 more
  • Next: 26-27 Apr 2023 Live online
  • Also: 19-20 Oct 2023 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Live online
Focused

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 30 Mar 2023 Live online
  • Also: 27-28 Jul 2023 Live online
  • Also: 8 Nov 2023 Live online

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.

  • 6 CPD hours
  • Presented by Andreas Rothmund
  • and Dr. Dale Charlton
  • Next: 17-18 Jan 2023 Live online
  • Also: 17-18 May 2023 Classroom
  • Also: 27-28 Sep 2023 Classroom

Process Validation with Qualification

Live online, 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
  • Next: 26 Jan 2023 Live online
  • Also: 8-9 May 2023 Live online
  • Also: 28 Sep 2023 Classroom

Quality Management Refresher

New for 2023

Live online, Classroom
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 9 Nov 2022 Live online

Registration of Feed Additives & Overview of Innovative Applications

New for 2022

Live online

This seminar, produced by Pen & Tec Consulting, has been designed to give a practical overview on how to register a feed additive in the EU.

  • Presented by Dr Eliana Henríquez Rodríguez
  • + 2 more
  • Next: 18-19 Jan 2023 Live online
  • Also: 4-5 May 2023 Live online
  • Also: 13-14 Sep 2023 Live online

Registration of Veterinary Vaccines in the USA and Canada

Live online

This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

  • 6 CPD hours
  • Presented by Nick Wills
  • Next: 30-31 Jan 2023 Live online
  • Also: 9-10 May 2023 Classroom
  • Also: 26-29 Sep 2023 Live online

Regulatory Affairs for Support Staff

Live online, 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
  • Next: on request

Regulatory Strategies for Orphan Drugs

Bespoke
Focused

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

  • 6 CPD hours
  • Next: 14 Oct 2022 Live online
  • Also: 27 Feb 2023 Live online
  • Also: 9 Jun 2023 Live online
  • Also: 13 Oct 2023 Live online

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
  • Next: 29-30 Nov 2022 Live online
  • Also: 17-18 Apr 2023 Live online
  • Also: 3-4 Jul 2023 Classroom
  • Also: 14-17 Nov 2023 Live online

Signal Detection and Regulatory Expectations

Live online, 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
  • Next: 16 Mar 2023 Live online
  • Also: 12 Jul 2023 Classroom
  • Also: 6-7 Nov 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online, Classroom
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 14-15 Nov 2022 Live online
  • Also: 6-9 Mar 2023 Live online
  • Also: 13-14 Jul 2023 Classroom
  • Also: 13-14 Nov 2023 Live online

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online, Classroom
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 Mr Paul Palmer
  • Next: 2-3 Feb 2023 Classroom
  • Also: 1-2 Jun 2023 Live online
  • Also: 19-20 Oct 2023 Live online

Sterilization of Medical Devices

New for 2023

Live online, Classroom
Focused

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 19-21 Apr 2023 Classroom
  • Also: 2-4 Aug 2023 Classroom
  • Also: 6-8 Dec 2023 Live online

Successful Medical Writing

Live online, 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
  • Webcast & report

Sustainable Design and Manufacture for Medical Devices

Webcast & report

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This free webinar will give you a high level of understanding of what sustainability options exist, what the benefits are and what drives them.

  • Presented by Cormac O'Prey
  • Next: 24 Jan 2023 Live online
  • Also: 27-28 Apr 2023 Live online
  • Also: 5 Jul 2023 Classroom
  • Also: 6 Oct 2023 Live online

Sustainable Design and Manufacture for Medical Devices

New for 2023

Live online, Classroom
Focused

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

  • 6 CPD hours
  • Presented by Cormac O'Prey
  • Next: on request

Technical Documentation to Comply with the MDR and IVDR

Bespoke
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
  • Next: 28-29 Nov 2022 Live online

The 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
  • and Marloes van der Geer
  • Next: 10-11 Oct 2022 Live online

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
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 5-9 Dec 2022 Live online
  • Also: 12-16 Jun 2023 Live online
  • Also: 4-8 Dec 2023 Live online

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 Adrian Keene
  • + 7 more
  • Next: on request

The New EU Animal Health Legislation for Veterinary Medicinal Products

Bespoke
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
  • Next: 3 Nov 2022 Live online
  • Also: 3 Mar 2023 Live online
  • Also: 17 Jul 2023 Live online
  • Also: 21 Nov 2023 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

New for 2022

Live online
Focused

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

  • 6 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 17-18 Nov 2022 Live online

Understanding Active Pharmaceutical Ingredients (APIs) - A Comprehensive and Practical Introduction

New for 2022

Live online
Focused

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 28-29 Nov 2022 Live online

Understanding Computer System Validation (CSV) - A Comprehensive and Practical Introduction

New for 2022

Live online
Focused

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 29 Nov 2022 Live online

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2022

Live online
High impact

‘Better regulation…for better trials…for better health’ The Medicines and Healthcare products Regulatory Agency (MHRA) have set far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. This webinar will bring you up-to-date with the current position regarding the proposals and the potential implications and opportunities for the industry.

  • 1.5 CPD hours
  • Presented by Dr David Jefferys
  • Next: 13-14 Oct 2022 Live online

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 Hans van Bruggen
  • + 2 more
  • Next: 13-14 Dec 2022 Live online
  • Also: 6-9 Mar 2023 Live online
  • Also: 13-14 Jul 2023 Classroom
  • Also: 12-13 Dec 2023 Live online

Veterinary Pharmaceutical Submissions in the EU

Live online, Classroom
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 Andrew Hewitt
  • + 2 more
  • Next: 19-22 Jun 2023 Classroom

Working Through Veterinary Drug Development in the EU and USA

Classroom
Intensive

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

  • 24 CPD hours
  • Presented by Andrew Hewitt
  • and David Petrick
  • Self-paced

Understanding the Pharmaceutical Industry

Self-paced

A 6 MODULE SELF-MANAGED DISTANCE LEARNING COURSE – An insider’s guide to the pharmaceutical industry for anyone new who wants to enhance their knowledge on working in the pharma, bio-tech or life sciences sectors. Gain key skills needed with this 6 module course requiring 3 to 4 hours study each module.

  • Mr John Ansell