Regulatory Training Courses

Our regulatory training courses have been designed to update delegates on a wide range of regulatory affairs 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.

  • Next: 12-13 Apr 2022 Live online
  • Also: 5-6 Jul 2022 Classroom
  • Also: 12-13 Oct 2022 Live online

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

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 17-18 Mar 2022 Live online
  • Also: 6-7 Sep 2022 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
  • and Dr Tamsin Dawson
  • Next: on request

A Regulatory Update on Animal Feed and Feed Additives in Europe the USA

Bespoke
Focused

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

  • 12 CPD hours
  • Next: 1-2 Mar 2022 Live online
  • Also: 27-28 Sep 2022 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 Ms Janette Benaddi
  • and Ms Theresa Jeary
  • Next: 23 May 2022 Live online
  • Also: 2 Nov 2022 Live online

An Essential Overview of the Medical Device Industry

Live online
Focused

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

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • Next: on request

An Essential Overview of the Medical Device Industry - the Key Considerations

Bespoke
High impact

This short and concise webinar will provide the essentials of how medical devices and diagnostics are regulated. With changes being introduced this summer, this is an event you cannot afford to miss! 90 minute live webinar 14:00 (UK/London Time Zone)

  • 1.5 CPD hours
  • Next: 1 Mar 2022 Live online
  • Also: 16 Sep 2022 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: 8-10 Feb 2022 Classroom
  • Also: 18-20 May 2022 Live online
  • Also: 1-3 Aug 2022 Classroom
  • Also: 8-10 Nov 2022 Live online

An Introduction to the Medical Device Regulation

Live online, Classroom
Focused

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

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • Next: on request

Basic Principles of Pharmacokinetics

Bespoke

An introduction and overview of the main principles and concepts of Pharmacokinetics relating to drug discovery and development.

  • 12 CPD hours
  • Next: 27 Jun 2022 Live online
  • Also: 19 Sep 2022 Classroom
  • Also: 12 Dec 2022 Live online

Best Practice for Writing Effective SOPs

Live online, Classroom
Focused

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

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 8-9 Feb 2022 Classroom
  • Also: 1-2 Aug 2022 Classroom

Biological Evaluation of Medical Devices

Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr Philip Clay
  • and Janine Ingleby
  • Next: 16 Jun 2022 Live online
  • Also: 1 Dec 2022 Live online

Borderlines between Medicines and Food

Live online
Focused

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

  • 6 CPD hours
  • Presented by David Richardson
  • + 2 more
  • Next: on request

Brexit Webinar - Impact on Pharmaceutical / Medical Devices Industries

Bespoke

Brexit Update - What will happen next? 14.15 (GMT)

  • 6 CPD hours
  • Next: 28 Jun 2022 Live online
  • Also: 20 Sep 2022 Classroom
  • Also: 13 Dec 2022 Live online

CAPA (Corrective and Preventative Action)

Live online, Classroom
Focused

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

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 30 Mar 2022 Live online
  • Also: 8 Sep 2022 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: on request

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

Bespoke
Focused

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

  • 12 CPD hours
  • Next: on request

Developing Medicines for Companion Animals in the EU

Bespoke

This In-house course will provide a comprehensive introduction to the entire development programme for companion animal medicines.

  • 18 CPD hours
  • Next: 10-11 Mar 2022 Live online
  • Also: 7-8 Jun 2022 Classroom
  • Also: 29-30 Sep 2022 Live online
  • Also: 14-15 Dec 2022 Classroom

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

Live online, Classroom
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 3 more
  • Next: on request

Effective Compliance with Good Marketing Practice in the Pharma Industry

Bespoke

This unique two-day In-house workshop will give you key insights into how the global, regional and national codes of practice work together to form a framework for compliance.

  • 12 CPD hours
  • Next: 11-12 Apr 2022 Live online
  • Also: 5-6 Jul 2022 Classroom
  • Also: 18-19 Oct 2022 Live online

EU Pharmaceutical Regulations & Strategy

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: on request

Exploring Routes to Market for Herbals

Bespoke

Acquire key skills to maximise success in an expanding herbal product market.

  • 6 CPD hours
  • Next: 23-24 Mar 2022 Live online
  • Also: 15-16 Jun 2022 Classroom
  • Also: 12-13 Sep 2022 Live online
  • Also: 5-6 Dec 2022 Classroom

FDA Approval Process for Medical Devices

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • Next: 18 Jan 2022 Live online
  • Also: 25 Apr 2022 Live online
  • Also: 11 Jul 2022 Classroom
  • Also: 19 Oct 2022 Live online

Filing eCTD Submissions

Live online, Classroom
Focused

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

  • 6 CPD hours
  • Presented by Maikel Bouman
  • and Marloes van der Geer
  • Next: on request

Impact of the Medical Device Regulation (MDR)

Bespoke

Are you prepared and what next? 14.00 (GMT)

  • 6 CPD hours
  • Next: on request

Intellectual Property for Pharma Regulatory Affairs

Bespoke

Understand the impact of IP on pharmaceutical regulatory strategy

  • 6 CPD hours
  • Next: on request

Introduction to the Development and Licensing of Veterinary Novel Biotherapeutics in the EU

Bespoke

In this In-house course, discover how to develop veterinary pharmaceuticals and vaccines, its regulatory landscape and how you might apply these principles to novel biotherapeutics.

  • 6 CPD hours
  • Next: 19-20 May 2022 Live online
  • Also: 3-4 Nov 2022 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: on request

ISO 13485: Quality Management Systems for Medical Devices

Bespoke

Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971 'Application to Risk Management to Medical Devices'.

  • 12 CPD hours
  • Next: on request

Medical Device Regulations in Asia-Pacific Markets

Bespoke

Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market.

  • 12 CPD hours
  • Next: 15-16 Jun 2022 Live online
  • Also: 20-21 Sep 2022 Classroom
  • Also: 7-8 Dec 2022 Live online

Medical Device Regulations in the Middle East and North Africa

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Ms Heba Hashem
  • and Ms Ilona Putz
  • Next: 25-28 Apr 2022 Live online
  • Also: 4-7 Jul 2022 Classroom
  • Also: 4-7 Oct 2022 Live online

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

Live online, Classroom
Focused

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

  • 18 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 12-13 Apr 2022 Live online
  • Also: 11-12 Jul 2022 Classroom
  • Also: 13-14 Oct 2022 Live online

New Medical Device Regulation

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • Next: on request

Periodic Safety Update Reports for Veterinary Medicinal Products

Bespoke
Focused

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit *NEW EVENT!*

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • Next: on request

Pharmaceutical Law Update

Bespoke

Protect your business by ensuring your legal team understand the impact and implications of recent legal changes and updates within the pharmaceutical industry with this *In-house* training programme.

  • 12 CPD hours
  • Next: 25-26 May 2022 Live online
  • Also: 23-24 Nov 2022 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

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

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • Next: 20-22 Apr 2022 Live online
  • Also: 12-14 Oct 2022 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 Ms Monica Dressler-Meyer
  • Next: 25-26 May 2022 Live online
  • Also: 22-23 Nov 2022 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 Ms Monica Dressler-Meyer
  • Next: 3-4 Feb 2022 Live online
  • Also: 15-16 Aug 2022 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 Mrs Anna Harrington-Morozova
  • Next: 29-30 Jun 2022 Live online
  • Also: 14-15 Dec 2022 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 Ms Heba Hashem
  • and Ms Ilona Putz
  • Next: on request

Pharmaceutical Regulatory Affairs in the Middle East, Dubai

Bespoke

This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.

  • 12 CPD hours
  • Next: 20-21 Jun 2022 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 Dr Elinor McCartney
  • Next: on request

Registration of Veterinary Vaccines in the USA and Canada

Bespoke

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
  • Next: 28-29 Mar 2022 Live online
  • Also: 27-28 Jun 2022 Classroom
  • Also: 27-28 Sep 2022 Live online

Regulatory Affairs for Support Staff

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 16 Mar 2022 Live online
  • Also: 27 Jun 2022 Classroom
  • Also: 26 Sep 2022 Live online

Regulatory Strategies for Orphan Drugs

Live online, Classroom
Focused

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

  • 6 CPD hours
  • Presented by Marloes van der Geer
  • Next: 29 Apr 2022 Live online
  • Also: 14 Oct 2022 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: 25-26 May 2022 Live online
  • Also: 22-23 Nov 2022 Live online

Technical Documentation to Comply with the MDR and IVDR

Live online
Focused

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

  • 12 CPD hours
  • Presented by Paul Sim
  • and Mr Will Burton
  • Next: on request

The end of the Brexit Transition Period – Impact on Medical Device Industry

Bespoke

The very latest information and operational experiences to be shared. 90 minute live webinar 14:00 (UK/London Time Zone)

  • 6 CPD hours
  • Next: on request

The end of the Brexit Transition Period – Impact on Pharmaceutical Industry

Bespoke

The very latest information and operational experiences to be shared. 90 minute live webinar 14:00 (UK/London Time Zone)

  • 6 CPD hours
  • Next: 21-22 Mar 2022 Live online
  • Also: 20-21 Jun 2022 Classroom
  • Also: 19-20 Sep 2022 Live online

The FDA Drug Approval Process

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Next: 13-17 Jun 2022 Live online
  • Also: 5-9 Dec 2022 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 Ms Janette Benaddi
  • Next: 16-17 May 2022 Live online
  • Also: 3-4 Nov 2022 Live online

The New EU Animal Health Legislation for Veterinary Medicinal Products

Live online
Focused

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

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • Self-paced

Understanding the Pharmaceutical Industry

Self-paced

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

  • Mr John Ansell
  • Next: 26-27 Apr 2022 Live online
  • Also: 13-14 Oct 2022 Live online

Variations to Marketing Authorisations

Live online
Focused

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

  • 12 CPD hours
  • Presented by Marloes van der Geer
  • Next: 9-10 Jun 2022 Live online
  • Also: 13-14 Dec 2022 Live online

Veterinary Pharmaceutical Submissions in the EU

Live online
Focused

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

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • Next: 20-24 Jun 2022 Live online
  • Also: 5-9 Dec 2022 Live online

Working Through Veterinary Drug Development in the EU and USA

Live online
Intensive

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

  • 24 CPD hours
  • Presented by David Petrick
  • and Dr Julian Braidwood