Scheduled In-house

Regulatory Affairs Training Courses

Our regulatory affairs training courses have been designed to update delegates on a wide range of regulatory topics, from updates on the latest regulations to registration procedures and strategies. We provide information on regulatory approval in key regions globally, with practical advice from our expert speaker panel.

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  • Next: 13-14 Feb 2025 Live online
  • Also: 3-4 Jun 2025 Live online
  • Also: 2-3 Oct 2025 Live online

Advanced Regulatory Affairs for Medical Devices

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • and Theresa Jeary
  • Next: 16 Oct 2024 Live online
  • Also: 27 Feb 2025 Live online
  • Also: 26 Jun 2025 Live online
  • Also: 23 Oct 2025 Live online

Animal Feed and Feed Additive Registration in China and Thailand

New for 2024

Live online

Learn how to navigate the regulatory system for animal feed and feed additives in two emerging markets.

  • 2.5 CPD hours High impact
  • Presented by Mrs Anongrut (Mai) Surarutrungsri
  • and Bi Jun
  • Next: 16-19 Jun 2025 Classroom

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

Summer school

Classroom

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

  • 24 CPD hours Intensive
  • Presented by Andrew Hewitt
  • and David Petrick
  • Next: 9 Apr 2025 Live online
  • Also: 17 Sep 2025 Live online
  • Also: 10 Dec 2025 Live online

Antimicrobial Resistance (AMR) and 'One Health': Current Challenges, Regulatory Frontiers and Future Solutions

New for 2025

Live online

This course will allow participants to explore the regulatory landscapes governing AMR, discover innovative solutions and understand the challenges AMR poses across different sectors.

  • 6 CPD hours Focused
  • Presented by Linda Oyama
  • Next: 12 Dec 2024 Live online
  • Also: 27 Mar 2025 Live online
  • Also: 17 Jul 2025 Live online
  • Also: 4 Dec 2025 Live online

Best Practice for Writing Effective SOPs

Live online

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 15-16 Jan 2025 Live online
  • Also: 15-16 May 2025 Live online
  • Also: 15-16 Sep 2025 Classroom

Biological Evaluation of Medical Devices

Live online, Classroom

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 Focused
  • Presented by Annette Callaghan
  • Next: 13 Dec 2024 Live online
  • Also: 28 Mar 2025 Live online
  • Also: 18 Jul 2025 Live online
  • Also: 5 Dec 2025 Live online

CAPA (Corrective and Preventative Action)

Live online

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 17-18 Oct 2024 Live online
  • Also: 27-28 Feb 2025 Live online
  • Also: 26-27 Jun 2025 Live online
  • Also: 20-21 Oct 2025 Live online

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

Live online

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 Focused
  • Presented by Andrew Willis
  • Next: 23-24 Oct 2024 Live online
  • Also: 5-6 Feb 2025 Live online
  • Also: 18-19 Jun 2025 Live online
  • Also: 1-2 Oct 2025 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online

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 Focused
  • Presented by Dr John Price
  • Next: 28 Nov 2024 Live online
  • Also: 13 Mar 2025 Live online
  • Also: 1 Jul 2025 Live online
  • Also: 28 Nov 2025 Live online

The Common Technical Document (CTD) Submission in the MENA Region

New for 2024

Live online

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

  • 6 CPD hours Focused
  • Presented by Mohammad Fat'hy Elnadi
  • Next: 15-16 Oct 2024 Live online
  • Also: 28-29 Jan 2025 Live online
  • Also: 8-9 May 2025 Live online
  • Also: 11-12 Sep 2025 Live online

Cyber Security for Medical Devices

Live online

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.

  • 12 CPD hours Focused
  • Presented by Ben Kokx
  • Next: 5 Nov 2024 Live online
  • Also: 5 Mar 2025 Live online
  • Also: 10 Jul 2025 Live online
  • Also: 5 Nov 2025 Live online

Deep Dive into the IVDR Annex XIII

New for 2024

Live online

Explore IVDR Annex XIII in-depth, covering Performance Evaluation, Performance Studies, and Post-market Performance. Learn what information is required, where to put it, and when, with a detailed review of nine essential documents.

  • 6 CPD hours Focused
  • Presented by Dr Jane Leadsham
  • Next: 29 Nov 2024 Live online
  • Also: 14 Mar 2025 Live online
  • Also: 18 Jul 2025 Live online
  • Also: 4 Dec 2025 Live online

An Essential Overview of Medical Information

Live online

In this one-day course, understand everything from the role of medical information to the guidelines for medical information and advertising.

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 8 Nov 2024 Live online
  • Also: 14 Mar 2025 Live online
  • Also: 3 Jul 2025 Live online
  • Also: 7 Nov 2025 Live online

An Essential Overview of the Medical Device Industry

Live online

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 Focused
  • Presented by Dr David Jefferys
  • and Theresa Jeary
  • Next: 16 Jan 2025 Live online
  • Also: 12 May 2025 Live online
  • Also: 22 Sep 2025 Live online

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 14-15 Oct 2024 Live online
  • Also: 10-11 Feb 2025 Live online
  • Also: 9-10 Jun 2025 Live online
  • Also: 6-7 Oct 2025 Live online

EU Pharmaceutical Regulations & Strategy

Live online

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation will be discussed in the relevant sections and impact on strategic considerations for obtaining and maintaining marketing authorisations Procedures for obtaining marketing authorisations in in the UK will be discussed.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 20 Jan 2025 Live online
  • Also: 19 May 2025 Live online
  • Also: 16 Sep 2025 Live online

EU Proposed Pharmaceutical Legislation Changes

Live online

This course will provide an up-to-date overview of current European pharmaceutical legislation and the regulatory impact of the proposed changes.

  • 3 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 2-3 Dec 2024 Live online
  • Also: 31 Mar-1 Apr 2025 Live online
  • Also: 22-23 Jul 2025 Live online
  • Also: 2-3 Dec 2025 Live online

FDA Approval Process for Medical Devices

Live online

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 Focused
  • Presented by Dr Jonathan Hughes
  • Next: 2-3 Dec 2024 Live online
  • Also: 24-25 Feb 2025 Live online
  • Also: 11-12 Jun 2025 Live online
  • Also: 7-8 Oct 2025 Live online

The FDA Drug Approval Process

Live online

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 9-13 Jun 2025 Live online

Global Pharmaceutical Regulatory Affairs Summer School

Summer school

Live online

Unlock the world of pharmaceutical regulatory excellence with our Global Pharmaceutical Regulatory Affairs training – an intensive journey through the diverse regions, offering practical insights, expert guidance, and strategic mastery for professionals seeking to navigate and succeed in the dynamic global regulatory landscape.

  • 84 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • + 8 more
  • Next: 5-6 Dec 2024 Live online
  • Also: 15-16 Jan 2025 Live online
  • Also: 13-14 May 2025 Live online
  • Also: 16-17 Sep 2025 Classroom

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

Live online, Classroom

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 Focused
  • Presented by Richard Featherstone
  • Next: 29 Jan 2025 Live online
  • Also: 12 May 2025 Live online
  • Also: 9 Sep 2025 Live online

ICH Q9(R1) Quality Risk Management (QRM)

Live online

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • 3 CPD hours High impact
  • Presented by Bruce Davis
  • Next: 11 Nov 2024 Live online
  • Also: 1 May 2025 Live online
  • Also: 10 Nov 2025 Live online

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

New for 2024

Live online

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

  • 3 CPD hours High impact
  • Presented by Annette Callaghan
  • Next: 23 Oct 2024 Live online
  • Also: 17 Mar 2025 Live online
  • Also: 9 Jul 2025 Classroom
  • Also: 20 Nov 2025 Live online

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

New for 2024

Live online, Classroom

This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.

  • 6 CPD hours Focused
  • Presented by Greg Thay
  • Next: 18 Nov 2024 Live online
  • Also: 22 May 2025 Live online
  • Also: 17 Nov 2025 Live online

An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

New for 2024

Live online

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

  • 3 CPD hours High impact
  • Presented by Annette Callaghan
  • Next: 20 Nov 2024 Live online
  • Also: 13 Mar 2025 Live online
  • Also: 3 Jul 2025 Live online
  • Also: 19 Nov 2025 Live online

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

New for 2024

Live online

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

  • 6 CPD hours Focused
  • Presented by Linda Garrod
  • and Nancy Consterdine
  • Next: 11 Mar 2025 Live online
  • Also: 11 Jul 2025 Live online
  • Also: 11 Nov 2025 Live online

An introduction to Risk Management ISO 14971:2019

New for 2025

Live online

Dive into the core principles of risk management using ISO14971:2019. Learn to assess, analyse, and mitigate risks effectively, ensuring compliance with international standards and enhancing decision-making in various industries.

  • 3 CPD hours High impact
  • Presented by Linda Garrod
  • Next: 5-8 Nov 2024 Live online
  • Also: 5-6 Feb 2025 Live online
  • Also: 16-17 Jul 2025 Live online
  • Also: 4-5 Nov 2025 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online

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 Focused
  • Presented by Stuart Angell
  • Next: 4-6 Nov 2024 Live online
  • Also: 25-27 Mar 2025 Live online
  • Also: 16-18 Jul 2025 Live online
  • Also: 3-5 Nov 2025 Live online

An Introduction to the Medical Device Regulation

Live online

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 Focused
  • Presented by Janette Benaddi
  • + 2 more
  • Next: 4 Nov 2024 Live online
  • Also: 4 Mar 2025 Live online
  • Also: 9 Jul 2025 Live online
  • Also: 4 Nov 2025 Live online

Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)

New for 2024

Live online

Understand the essentials of performance evaluation under the In Vitro Diagnostic Regulation (2017/746) in this comprehensive seminar. Essential for regulatory compliance and business success.

  • 6 CPD hours Focused
  • Presented by Dr Jane Leadsham
  • Next: 5 Nov 2024 Live online
  • Also: 26 Mar 2025 Live online
  • Also: 11 Jul 2025 Live online
  • Also: 11 Nov 2025 Live online

Managing Competence within the Medical Device Industry

New for 2024

Live online

This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.

  • 1.5 CPD hours High impact
  • Presented by Anne Jury
  • Next: 9-10 Dec 2024 Live online
  • Also: 3-4 Apr 2025 Live online
  • Also: 23-24 Jul 2025 Live online
  • Also: 8-9 Dec 2025 Live online

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

Live online

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 Focused
  • Presented by Anna Harrington-Morozova
  • Next: 7-8 Oct 2024 Live online
  • Also: 10-11 Mar 2025 Live online
  • Also: 23-24 Jul 2025 Live online
  • Also: 19-20 Nov 2025 Live online

Medical Device Regulations in the Middle East and North Africa

Live online

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 Focused
  • Presented by Heba Hashem
  • and Ilona Putz
  • Next: 2-6 Dec 2024 Live online
  • Also: 9-13 Jun 2025 Classroom

The Medical Device School - From Concept to CE Marking

Summer school

Live online, Classroom

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 Intensive
  • Presented by Adrian Keene
  • + 7 more
  • Next: 28-29 Nov 2024 Live online
  • Also: 24-25 Mar 2025 Live online
  • Also: 10-11 Jul 2025 Live online
  • Also: 26-27 Nov 2025 Live online

Medical Device Single Audit Programme (MDSAP)

Live online

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 Focused
  • Presented by Stuart Angell
  • Next: 18-21 Nov 2024 Live online

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

Live online

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

  • 24 CPD hours Focused
  • Presented by Koen Cobbaert
  • and Zuzanna Kwade
  • Next: 12 Feb 2025 Live online
  • Also: 23 Jun 2025 Live online
  • Also: 23 Oct 2025 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 High impact
  • Presented by April Wang
  • and Helen Ye
  • Next: 21-22 Jan 2025 Live online
  • Also: 19-20 May 2025 Live online
  • Also: 10-11 Sep 2025 Live online

Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

Live online

Gain practical guidance on the complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

  • 12 CPD hours Focused
  • Presented by Dr David Jefferys
  • + 3 more
  • Next: 14 Nov 2024 Live online
  • Also: 6 Mar 2025 Live online
  • Also: 26 Jun 2025 Live online
  • Also: 6 Nov 2025 Live online

Navigating Regulatory Compliance Whilst Developing and Distributing PCR-Based IVD Tests

New for 2024

Live online

In this three-hour course, learn from an expert about developing and distributing PCR-based IVD tests, as well as exploring the latest regulatory requirements.

  • 3 CPD hours High impact
  • Presented by Dmitriy Kosarikov
  • Next: 12 Dec 2024 Live online
  • Also: 10 Apr 2025 Live online
  • Also: 18 Jul 2025 Live online
  • Also: 11 Dec 2025 Live online

Non-Conformance and Corrective Action for Medical Device Manufacturers

New for 2024

Live online

The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan
  • Next: 19-20 Nov 2024 Live online
  • Also: 24-25 Feb 2025 Live online
  • Also: 16-17 Jun 2025 Live online
  • Also: 21-22 Oct 2025 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online

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 Focused
  • Presented by Makram Nehme
  • and Salma Ismail
  • Next: 9-11 Oct 2024 Live online
  • Also: 25-27 Feb 2025 Live online
  • Also: 11-13 Jun 2025 Live online
  • Also: 8-10 Oct 2025 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online

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 Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer
  • Next: 10-11 Dec 2024 Live online
  • Also: 31 Mar-1 Apr 2025 Live online
  • Also: 25-26 Jun 2025 Live online
  • Also: 26-27 Nov 2025 Live online

Pharmaceutical Regulatory Affairs in China

Live online

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

  • 12 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer
  • Next: 22 Oct 2024 Live online
  • Also: 25 Feb 2025 Live online
  • Also: 18 Jun 2025 Live online
  • Also: 22 Oct 2025 Live online

Pharmaceutical Regulatory Affairs in Latin America

New for 2024

Live online

This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.

  • 6 CPD hours Focused
  • Presented by Belkys Ruiz
  • Next: 6-7 Feb 2025 Live online
  • Also: 19-20 Jun 2025 Live online
  • Also: 2-3 Oct 2025 Live online

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online

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 Focused
  • Presented by Anna Harrington-Morozova
  • Next: 9-10 Dec 2024 Live online
  • Also: 25-26 Feb 2025 Live online
  • Also: 23-24 Jun 2025 Live online
  • Also: 21-22 Oct 2025 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online

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

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz
  • Next: 12 Feb 2025 Live online
  • Also: 5 Jun 2025 Live online
  • Also: 9 Oct 2025 Live online

Post-Market Surveillance - Practical Application for Medical Devices and IVDs

Live online

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

  • 6 CPD hours Focused
  • Presented by Anne Jury
  • and Karen Pearson
  • Next: 5 Nov 2024 Live online
  • Also: 1 May 2025 Live online
  • Also: 4 Nov 2025 Live online

A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products

New for 2024

Live online

Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU.

  • 6 CPD hours Focused
  • Presented by Mr Craig Evans
  • and Dave Parry
  • Next: 11-12 Nov 2024 Live online
  • Also: 13-14 May 2025 Live online
  • Also: 6-7 Nov 2025 Live online

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

Live online

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 Focused
  • Presented by Dr Mel Munro
  • Next: 5-6 Nov 2024 Live online
  • Also: 4-5 Mar 2025 Live online
  • Also: 1-2 Jul 2025 Live online
  • Also: 18-19 Nov 2025 Live online

Practical Implementation of a Human Factors Study

New for 2024

Live online

This training focuses on the practical and logistical aspects of planning, preparing and performing human factors studies for medical devices and combination products.

  • 12 CPD hours Focused
  • Presented by Richard Featherstone
  • Next: 27 Feb 2025 Live online
  • Also: 26 Jun 2025 Live online
  • Also: 23 Oct 2025 Live online

Registration of Veterinary Pharmaceuticals in China

New for 2025

Live online

Learn how to navigate the regulatory system of veterinary pharmaceuticals in China.

  • 1.5 CPD hours High impact
  • Presented by Bi Jun
  • Next: 27-28 Jan 2025 Live online
  • Also: 12-13 May 2025 Classroom
  • Also: 22-23 Sep 2025 Live online

Regulatory Affairs for Support Staff

Live online, Classroom

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 Focused
  • Presented by Norah Lightowler
  • Next: 8 Oct 2024 Live online
  • Also: 10 Feb 2025 Live online
  • Also: 23 Jun 2025 Live online
  • Also: 7 Oct 2025 Live online

Regulatory Strategies for Orphan Drugs

Live online

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

  • 6 CPD hours Focused
  • Presented by Shaun Stapleton
  • Next: 2-3 Dec 2024 Live online

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

Live online

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China.

  • 6 CPD hours Focused
  • Presented by Dr Andrew Bell
  • + 5 more
  • Next: 22 Oct 2024 Live online
  • Also: 30 Apr 2025 Live online
  • Also: 21 Oct 2025 Live online

A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK

Live online

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

  • 6 CPD hours Focused
  • Presented by Sue Spencer
  • + 4 more
  • Next: 8 Oct 2024 Live online
  • Also: 4 Feb 2025 Live online
  • Also: 6 Jun 2025 Live online
  • Also: 7 Oct 2025 Live online

Risk Management for Pharma and Biopharma Professionals

Live online

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 Focused
  • Presented by Dr Laura Brown
  • Next: 23 Jan 2025 Live online
  • Also: 22 May 2025 Classroom
  • Also: 22 Sep 2025 Live online

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

Live online, Classroom

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 Focused
  • Presented by Stuart Angell
  • Next: 17-18 Oct 2024 Live online
  • Also: 3-4 Feb 2025 Live online
  • Also: 5-6 Jun 2025 Live online
  • Also: 16-17 Oct 2025 Live online

Sterilization of Medical Devices

Live online

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 Focused
  • Presented by Annette Callaghan
  • Next: 10 Feb 2025 Live online
  • Also: 26 Jun 2025 Live online
  • Also: 21 Oct 2025 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online

This course provides 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.

  • 6 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 18-19 Nov 2024 Live online
  • Also: 25-26 Mar 2025 Live online
  • Also: 16-17 Jul 2025 Live online
  • Also: 19-20 Nov 2025 Live online

Understanding Active Pharmaceutical Ingredients (APIs)

Live online

This course 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 Focused
  • Presented by Farah Nadeem
  • and Paul Palmer
  • Next: 4-5 Nov 2024 Live online
  • Also: 18-19 Mar 2025 Live online
  • Also: 9-10 Jul 2025 Live online
  • Also: 24-25 Nov 2025 Live online

Understanding Computer System Validation (CSV)

Live online

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.

  • 12 CPD hours Focused
  • Presented by Farah Nadeem
  • and Paul Palmer
  • Next: 5 Dec 2024 Live online
  • Also: 24 Mar 2025 Live online
  • Also: 8 Jul 2025 Live online
  • Also: 20 Nov 2025 Live online

Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers

New for 2024

Live online

The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.

  • 3 CPD hours High impact
  • Presented by Annette Callaghan
  • Next: 27 Nov 2024 Live online
  • Also: 13 Mar 2025 Live online
  • Also: 11 Jul 2025 Live online
  • Also: 26 Nov 2025 Live online

US FDA - Understanding Key Factors When Working with the FDA

New for 2024

Live online

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 Focused
  • Presented by Andrew Willis
  • Next: 28-29 Nov 2024 Live online
  • Also: 6-7 Feb 2025 Live online
  • Also: 3-4 Jun 2025 Live online
  • Also: 15-16 Oct 2025 Live online

Variations to Marketing Authorisations

Live online

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 Focused
  • Presented by Andrew Willis
  • Next: 26-27 Nov 2024 Classroom
  • Also: 19-20 May 2025 Live online
  • Also: 25-26 Nov 2025 Classroom

Veterinary Pharmaceutical Submissions in the EU

Live online, Classroom

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

  • 12 CPD hours Focused
  • Presented by Andrew Hewitt
  • and Dave Parry
  • Recorded webcast

Human Factors - The Increasing Importance of Instructions for Use

Free + recorded

Recorded webcast

This free webinar will focus on the often overlooked but increasingly important area of instructions for use for medical products.

  • 1.5 CPD hours High impact
  • Presented by Greg Thay
  • 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.

  • John Ansell