Scheduled In-house

Life Sciences Training Courses

Our life sciences training courses cover Pharmaceuticals, Medical Devices, IVDs, Biotech/Biopharma and Animal Health and have been designed to focus on regulatory affairs, clinical trials, pharmacovivilance, medical writing, latest developments, and best practices (GxP).  Our portfolio of events is extensive and provides training from basic to advanced levels in a variety of formats.  

The pandemic created numerous challenges across all areas of business worldwide and companies had to respond and adapt very quickly. Now, as the healthcare sector emerges stronger and with renewed strategy, life science companies continue to focus on key areas for development, explore the use of emerging technologies, and seek opportunities to harness collaborations and build resilience. 

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  • Next: 5-6 Jun 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: 6-7 Jun 2023 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 Andrew Willis
  • Next: 6 Jun 2023 Live online

Delivery of Biologics to the Nasal Cavity

New for 2023

Live online
Focused

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

  • 3 CPD hours
  • Presented by Dr Irene Rossi
  • + 3 more
  • Next: 7-9 Jun 2023 Classroom

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
  • Next: 8 Jun 2023 Live online

New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers

Free

Live online
High impact

This free webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be covered will include how to prepare your Contamination Control Strategy (CCS) document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.

  • 1.5 CPD hours
  • Presented by Mustafa Edik
  • Next: 12-16 Jun 2023 Live online

The Medical Device School - From Concept to CE Marking

Summer school

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
  • + 6 more
  • Next: 13-14 Jun 2023 Live online

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 Heba Hashem
  • and Ilona Putz
  • Next: 14-15 Jun 2023 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 Sara Magalhães
  • Next: 14-16 Jun 2023 Live online

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 Monica Dressler-Meyer
  • Next: 19-20 Jun 2023 Live online

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 Caroline Idowu
  • and Rocío Duchén Bocángel
  • Next: 19-22 Jun 2023 Classroom

The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA

Summer school

Classroom
Intensive

This practical four-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
  • Next: 20-21 Jun 2023 Live online

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
  • Presented by Andrew Willis
  • Next: 21-22 Jun 2023 Live online

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
  • Next: 26-29 Jun 2023 Live online

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 Anna Harrington-Morozova
  • Next: 26-30 Jun 2023 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 Mardon McFarlane
  • + 6 more
  • Next: 26 Jun 2023 Live online

Regulatory Strategies for Orphan Drugs

Live online
Focused

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

  • 6 CPD hours
  • Presented by Andrew Willis
  • Next: 27-28 Jun 2023 Live online

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
  • Presented by Andrew Willis
  • Next: 28-29 Jun 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: 29-30 Jun 2023 Live online

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 Declan O'Rourke
  • Next: 30 Jun 2023 Live online

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 Barbara Grossman
  • Next: 3 Jul 2023 Live online

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 and update on the New ICH GCP R3 guideline.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 3-4 Jul 2023 Live online

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 David Howlett
  • Next: 3-6 Jul 2023 Classroom

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.

  • 24 CPD hours
  • Presented by Koen Cobbaert
  • and Zuzanna Kwade
  • Next: 3-4 Jul 2023 Live online

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
  • Next: 4-5 Jul 2023 Live online

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 Barbara Grossman
  • and Gerry McGregor
  • Next: 4-5 Jul 2023 Live online

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 Anna Harrington-Morozova
  • Next: 4-5 Jul 2023 Live online

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 Monica Dressler-Meyer
  • Next: 6-7 Jul 2023 Live online

Medical Device Single Audit Programme (MDSAP)

New for 2023

Live online
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 Stuart Angell
  • Next: 6-7 Jul 2023 Live online

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

New for 2023

Live online
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 Andrew Willis
  • Next: 7 Jul 2023 Live online

Masterclass: Artificial Intelligence-enabled Medical Devices

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 Koen Cobbaert
  • Next: 10-11 Jul 2023 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 Jul 2023 Live online

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 10-11 Jul 2023 Live online

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
  • Next: 10-11 Jul 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 Theresa Jeary
  • Next: 10-11 Jul 2023 Live online

Understanding Pharmacovigilance Regulations in APAC

New for 2023

Live online
Focused

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours
  • Presented by Helen Ye
  • + 4 more
  • Next: 12-13 Jul 2023 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: 12 Jul 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online
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 Graham Howieson
  • Next: 12-13 Jul 2023 Live online

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 Dr Mary-Ann Preston
  • Next: 13-14 Jul 2023 Live online

Cyber Security for Medical Devices

Live online
Focused

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 Ben Kokx
  • Next: 13-14 Jul 2023 Live online

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 Paul Palmer
  • Next: 17-18 Jul 2023 Live online

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 Donna Taylor
  • + 2 more
  • Next: 17-20 Jul 2023 Live online

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 Richard Featherstone
  • Next: 17 Jul 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: 17 Jul 2023 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

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 Dr Tina Amini
  • Next: 18-19 Jul 2023 Live online

Effective Technology Transfer

Live online
Focused

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

  • 12 CPD hours
  • Presented by Bruce Davis
  • Next: 18 Jul 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: 19-20 Jul 2023 Live online

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 Heba Hashem
  • and Ilona Putz
  • Next: 19-20 Jul 2023 Live online

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

New for 2023

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 Paul Palmer
  • Next: 19-20 Jul 2023 Live online

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2023

Live online
Focused

This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.

  • 12 CPD hours
  • Presented by Mustafa Edik
  • Next: 20-21 Jul 2023 Live online

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding and update from Go Live from 2022 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: 20 Jul 2023 Live online

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 Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 21 Jul 2023 Live online

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
  • Next: 24 Jul 2023 Live online

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
  • Next: 24 Jul 2023 Live online

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
  • Next: 25 Jul 2023 Live online

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
  • Next: 25-26 Jul 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 Makram Nehme
  • and Salma Ismail
  • Next: 26 Jul 2023 Live online

Sustainable Design and Manufacture for Medical Devices

New for 2023

Live online
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: 26-27 Jul 2023 Live online

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
  • Next: 26-27 Jul 2023 Live online

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

New for 2023

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 Paul Palmer
  • Next: 27-28 Jul 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: 1 Aug 2023 Live online

Navigating China’s API Regulations: An Essential Guide to DMF Registration

New for 2023

Live online

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

  • 1.5 CPD hours
  • Presented by Helen Ye
  • and Raymond Ng
  • Next: 2-4 Aug 2023 Live online

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 Theresa Jeary
  • and Will Burton
  • Next: 2-4 Aug 2023 Classroom

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 Barbara Grossman
  • and Dr James Visanji
  • Next: 7-8 Aug 2023 Live online

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 Dr Mary-Ann Preston
  • Next: 11-12 Sep 2023 Live online

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
  • Next: 13-14 Sep 2023 Live online

Registration of Veterinary Vaccines in the USA and Canada

Updated for 2023

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: 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: 18-19 Sep 2023 Live online

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 one year on and a brief review of key FDA requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 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 Philip Clay
  • and Rona Middlemiss
  • Next: 18-19 Sep 2023 Classroom

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
  • Next: 18-19 Sep 2023 Live online

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 Dr Graeme Ladds
  • Next: 19 Sep 2023 Live online

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

New for 2023

Live online

This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.

  • 6 CPD hours
  • Presented by Nancy Consterdine
  • Next: 20-22 Sep 2023 Live online

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
  • Next: 20 Sep 2023 Live online

Artificial Intelligence and Machine Learning Powered Signal Management

New for 2023

Live online
Focused

This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

  • 6 CPD hours
  • Presented by Dr Sanjeev Srivastav
  • Next: 20 Sep 2023 Live online

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

New for 2023

Live online

An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.

  • Presented by Professor John E. Harrison
  • Next: 21-22 Sep 2023 Live online

Drug Discovery: A Step-by-Step Introduction

New for 2023

Live online
Focused

This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.

  • 12 CPD hours
  • Presented by Dr Peter A. Lowe
  • Next: 26-27 Sep 2023 Live online

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 David Howlett
  • Next: 26-29 Sep 2023 Live online

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 Norah Lightowler
  • Next: 26 Sep 2023 Live online

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2023

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: 27-28 Sep 2023 Live online

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 Bruce Davis
  • Next: 27-29 Sep 2023 Classroom

An Introduction to Pharmaceutical Packaging

Classroom
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 Chris Penfold
  • Next: 27-29 Sep 2023 Classroom

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
  • + 5 more
  • Next: 27 Sep 2023 Live online

Metrics and Earned Value in Clinical Research Projects

New for 2023

Live online
Masterclass

This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.

  • 3 CPD hours
  • Presented by Roger Joby
  • Next: 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: 2-3 Oct 2023 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: 2-5 Oct 2023 Live online

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 Heba Hashem
  • and Ilona Putz
  • Next: 2-4 Oct 2023 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge

New for 2023

Live online
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: 3 Oct 2023 Live online

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 Barbara Grossman
  • Next: 4-5 Oct 2023 Live online

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 Declan O'Rourke
  • Next: 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: 5 Oct 2023 Live online

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
  • Next: 5-6 Oct 2023 Live online

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 David Howlett
  • Next: 5-6 Oct 2023 Live online

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 Anna Harrington-Morozova
  • Next: 6 Oct 2023 Live online

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
  • Next: 6 Oct 2023 Classroom

Sustainable Design and Manufacture for Medical Devices

New for 2023

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: 6 Oct 2023 Live online

Clinical Research - A Different Approach to Successful Project Delivery

New for 2023

Live online

This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.

  • 6 CPD hours
  • Presented by Roger Joby
  • Next: 9-12 Oct 2023 Live online

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
  • Presented by Andrew Willis
  • Next: 9-10 Oct 2023 Live online

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 Theresa Jeary
  • Next: 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: 9-10 Oct 2023 Live online

Cosmetovigilance

Updated for 2023

Live online
Focused

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 10-11 Oct 2023 Live online

Cyber Security for Medical Devices

Live online
Focused

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 Ben Kokx
  • Next: 10 Oct 2023 Live online

Delivery of Biologics to the Nasal Cavity

New for 2023

Live online
Focused

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

  • 3 CPD hours
  • Presented by Dr Irene Rossi
  • + 3 more
  • Next: 10-11 Oct 2023 Live online

Understanding Pharmacovigilance Regulations in APAC

New for 2023

Live online
Focused

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours
  • Presented by Helen Ye
  • + 4 more
  • Next: 11-13 Oct 2023 Live online

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 Monica Dressler-Meyer
  • Next: 11-13 Oct 2023 Live online

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
  • + 4 more
  • Next: 12-13 Oct 2023 Classroom

Effective Technology Transfer

Classroom
Focused

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

  • 12 CPD hours
  • Presented by Bruce Davis
  • Next: 12-13 Oct 2023 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 Marloes van der Geer
  • Next: 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: 16-17 Oct 2023 Live online

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
  • Presented by Andrew Willis
  • Next: 16-17 Oct 2023 Live online

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, including discussion of the proposed changes to EU pharmaceuticals legislation. 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 Norah Lightowler
  • Next: 17 Oct 2023 Live online

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 Mercia Lucouw
  • and Maikel Bouman
  • Next: 18-19 Oct 2023 Live online

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 Declan O'Rourke
  • Next: 19-20 Oct 2023 Live online

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 19-20 Oct 2023 Live online

Sterilization of Medical Devices

New for 2023

Live online
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: 19-20 Oct 2023 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Updated for 2023

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: 20 Oct 2023 Live online

US FDA - Understanding Key Factors When Working with the FDA

New for 2023

Live online
Focused

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

  • 6 CPD hours
  • Presented by Andrew Willis
  • Next: 26-27 Oct 2023 Live online

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

New for 2023

Live online
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 Andrew Willis
  • Next: 27 Oct 2023 Live online

Regulatory Strategies for Orphan Drugs

Live online
Focused

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

  • 6 CPD hours
  • Presented by Joanne Roza
  • Next: 30-31 Oct 2023 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: 6-8 Nov 2023 Live online

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 Theresa Jeary
  • and Will Burton
  • Next: 6-7 Nov 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online
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 Graham Howieson
  • Next: 6-10 Nov 2023 Live online

European Post Marketing Pharmacovigilance - Including the EMA/PRAC deliberations and Brexit implications

New for 2023

Live online
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: 7-10 Nov 2023 Live online

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
  • Next: 8-9 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: 9 Nov 2023 Live online

Masterclass: Artificial Intelligence-enabled Medical Devices

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 Koen Cobbaert
  • Next: 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 Theresa Jeary
  • Next: 13-14 Nov 2023 Live online

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding and update from Go Live from 2022 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: 13-14 Nov 2023 Live online

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 Dr Mary-Ann Preston
  • Next: 13-14 Nov 2023 Live online

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 Paul Palmer
  • Next: 13-14 Nov 2023 Classroom

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

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
  • Next: 14-17 Nov 2023 Live online

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
  • Next: 15-16 Nov 2023 Live online

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
  • Next: 16-17 Nov 2023 Live online

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
  • Next: 20-21 Nov 2023 Live online

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

New for 2023

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 Paul Palmer
  • Next: 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 Makram Nehme
  • and Salma Ismail
  • Next: 21 Nov 2023 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

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 Dr Tina Amini
  • Next: 21-24 Nov 2023 Live online

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2023

Live online
Focused

This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.

  • 12 CPD hours
  • Presented by Mustafa Edik
  • Next: 23-24 Nov 2023 Live online

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 Barbara Grossman
  • and Gerry McGregor
  • Next: 24 Nov 2023 Live online

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 and update on the New ICH GCP R3 guideline.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 27-28 Nov 2023 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: 27-28 Nov 2023 Live online

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

New for 2023

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 Paul Palmer
  • Next: 28-29 Nov 2023 Classroom

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 Donna Taylor
  • and Jenny Webster
  • Next: 28-29 Nov 2023 Live online

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 Richard Featherstone
  • Next: 29-30 Nov 2023 Live online

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 Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 29-30 Nov 2023 Live online

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 Dr Mary-Ann Preston
  • Next: 30 Nov-1 Dec 2023 Live online

Medical Device Single Audit Programme (MDSAP)

New for 2023

Live online
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 Nancy Consterdine
  • Next: 1 Dec 2023 Live online

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
  • Next: 1 Dec 2023 Live online

An Essential Overview of Medical Information

Updated for 2023

Live online
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: 4-5 Dec 2023 Live online

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
  • Next: 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
  • + 6 more
  • Next: 4-5 Dec 2023 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
  • Next: 4-8 Dec 2023 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
  • + 5 more
  • Next: 6-8 Dec 2023 Live online

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 Barbara Grossman
  • and Dr James Visanji
  • Next: 11-14 Dec 2023 Live online

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.

  • 24 CPD hours
  • Presented by Koen Cobbaert
  • and Zuzanna Kwade
  • Next: 11-12 Dec 2023 Live online

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 Anna Harrington-Morozova
  • Next: 11-14 Dec 2023 Live online

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 Heba Hashem
  • and Ilona Putz
  • Next: 11-15 Dec 2023 Live online

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
  • Next: 12-13 Dec 2023 Live online

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 Monica Dressler-Meyer
  • Next: 12-13 Dec 2023 Classroom

Veterinary Pharmaceutical Submissions in the EU

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: 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: 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: 23-24 Jan 2024 Live online

Understanding Pharmacovigilance Regulations in APAC

Live online
Focused

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours
  • Presented by Helen Ye
  • + 4 more
  • Next: 24 Jan 2024 Live online

Artificial Intelligence and Machine Learning Powered Signal Management

Live online
Focused

This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

  • 6 CPD hours
  • Presented by Dr Sanjeev Srivastav
  • Next: 1 Feb 2024 Live online

Navigating China’s API Regulations: An Essential Guide to DMF Registration

Live online

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

  • 1.5 CPD hours
  • Presented by Helen Ye
  • and Raymond Ng
  • Next: 20 Mar 2024 Live online

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

Live online

An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.

  • Presented by Professor John E. Harrison
  • Next: 23-24 Apr 2024 Live online

Understanding Pharmacovigilance Regulations in APAC

Live online
Focused

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours
  • Presented by Helen Ye
  • + 4 more
  • Next: 15 May 2024 Live online

Artificial Intelligence and Machine Learning Powered Signal Management

Live online
Focused

This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

  • 6 CPD hours
  • Presented by Dr Sanjeev Srivastav
  • Next: 18 Sep 2024 Live online

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

Live online

An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.

  • Presented by Professor John E. Harrison