Scheduled In-house

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

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

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Mel Munro
  • and Dr Tamsin Dawson
  • Next: 27-28 Sep 2022 Live online
  • Also: 2-3 Feb 2023 Live online
  • Also: 6-9 Jun 2023 Live online
  • Also: 9-10 Oct 2023 Classroom

Advanced Regulatory Affairs for Medical Devices

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • and Ms Theresa Jeary
  • Next: 1 Dec 2022 Live online
  • Also: 1 Jun 2023 Classroom
  • Also: 1 Dec 2023 Live online

An Essential Overview of Medical Information

Live online, Classroom
Focused

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

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

An Essential Overview of the Medical Device Industry

Live online
Focused

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

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • Next: 20 Jan 2023 Live online
  • Also: 12 May 2023 Live online
  • Also: 15 Sep 2023 Live online

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online
Focused

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

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 8-10 Nov 2022 Live online
  • Also: 7-9 Feb 2023 Live online
  • Also: 17-19 May 2023 Live online
  • + 2 more

An Introduction to the Medical Device Regulation

Live online, Classroom
Focused

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

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • Next: 12 Dec 2022 Live online
  • Also: 28 Apr 2023 Live online
  • Also: 17 Jul 2023 Live online
  • Also: 14 Dec 2023 Live online

Best Practice for Writing Effective SOPs

Live online
Focused

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

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 23-24 Mar 2023 Classroom
  • Also: 18-19 Sep 2023 Classroom

Biological Evaluation of Medical Devices

Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr Philip Clay
  • and Rona Middlemiss
  • Next: 1 Dec 2022 Live online
  • Also: 26-27 Apr 2023 Live online
  • Also: 14 Jul 2023 Live online
  • Also: 1 Dec 2023 Live online

Borderlines between Medicines and Food

Live online
Focused

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

  • 6 CPD hours
  • Presented by Mr Brian Kelly
  • and Ms Penny Viner
  • Next: 27 Sep 2022 Live online
  • Also: 13 Dec 2022 Live online
  • Also: 27 Apr 2023 Live online
  • + 2 more

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: 20-21 Oct 2022 Classroom
  • Also: 2-3 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Classroom
  • Also: 26-27 Oct 2023 Live online

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

New for 2022

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 5-6 Oct 2022 Live online
  • Also: 8-9 Feb 2023 Live online
  • Also: 21-22 Jun 2023 Live online
  • Also: 4-5 Oct 2023 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

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

  • 6 CPD hours
  • Presented by Dr John Price
  • Next: 11 Oct 2022 Live online
  • Also: 20 Jan 2023 Live online
  • Also: 28 Apr 2023 Live online
  • + 2 more

Cyber Security for Medical Devices

Live online, Classroom
Focused

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

  • 6 CPD hours
  • Presented by Mr Ben Kokx
  • Next: 29-30 Sep 2022 Live online
  • Also: 14-15 Dec 2022 Classroom
  • Also: 8-9 Mar 2023 Live online
  • + 3 more

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: 18-19 Oct 2022 Live online
  • Also: 20-23 Feb 2023 Live online
  • Also: 13-14 Jun 2023 Classroom
  • Also: 16-17 Oct 2023 Live online

EU Pharmaceutical Regulations & Strategy

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 5-6 Dec 2022 Classroom
  • Also: 21-24 Mar 2023 Live online
  • Also: 21-22 Jun 2023 Live online
  • + 2 more

FDA Approval Process for Medical Devices

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • Next: 19 Oct 2022 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 Mercia Lucouw
  • Next: 3-4 Nov 2022 Live online
  • Also: 9-10 Mar 2023 Live online
  • Also: 26-27 Jul 2023 Classroom
  • Also: 7-10 Nov 2023 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • Next: 18-21 Apr 2023 Live online
  • Also: 4-5 Jul 2023 Classroom
  • Also: 11-12 Dec 2023 Live online

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

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 7-8 Dec 2022 Live online
  • Also: 6-7 Feb 2023 Live online
  • Also: 13-14 Jun 2023 Classroom
  • Also: 2-5 Oct 2023 Live online

Medical Device Regulations in the Middle East and North Africa

Live online, Classroom
Focused

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

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

Medical Device Single Audit Programme (MDSAP)

New for 2022

Live online, Classroom
Focused

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

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

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

Live online, Classroom
Focused

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

  • 24 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 21-24 Feb 2023 Live online
  • Also: 29-30 Jun 2023 Classroom
  • Also: 2-3 Oct 2023 Live online

New Regulations for Medical Devices and IVDs in Europe

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • Next: 23-24 Nov 2022 Live online
  • Also: 2-3 Mar 2023 Live online
  • Also: 25-26 Jul 2023 Live online
  • Also: 21-24 Nov 2023 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

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

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • Next: 8-10 Nov 2022 Live online
  • Also: 22-24 Feb 2023 Live online
  • Also: 14-16 Jun 2023 Classroom
  • Also: 11-13 Oct 2023 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online, Classroom
Focused

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

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 22-23 Nov 2022 Live online
  • Also: 17-18 Apr 2023 Live online
  • Also: 13-14 Jul 2023 Classroom
  • Also: 12-13 Dec 2023 Live online

Pharmaceutical Regulatory Affairs in China

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 16-17 Nov 2022 Live online
  • Also: 9-10 Feb 2023 Live online
  • Also: 26-29 Jun 2023 Live online
  • Also: 5-6 Oct 2023 Classroom

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 14-15 Dec 2022 Live online
  • Also: 24-25 Apr 2023 Live online
  • Also: 19-20 Jul 2023 Classroom
  • Also: 11-14 Dec 2023 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: on request

Registration of Animal Feed Additives in the EU

Bespoke
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
  • Next: 9 Nov 2022 Live online

Registration of Feed Additives & Overview of Innovative Applications

New for 2022

Live online

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

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

Registration of Veterinary Vaccines in the USA and Canada

Live online

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

  • 6 CPD hours
  • Presented by Nick Wills
  • Next: 27-28 Sep 2022 Live online
  • Also: 30-31 Jan 2023 Live online
  • Also: 9-10 May 2023 Classroom
  • Also: 26-29 Sep 2023 Live online

Regulatory Affairs for Support Staff

Live online, Classroom
Focused

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

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

Regulatory Strategies for Orphan Drugs

Bespoke
Focused

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

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

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

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

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 20-21 Oct 2022 Live online
  • Also: 2-3 Feb 2023 Classroom
  • Also: 1-2 Jun 2023 Live online
  • Also: 19-20 Oct 2023 Live online

Sterilization of Medical Devices

New for 2022

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: on request

Technical Documentation to Comply with the MDR and IVDR

Bespoke
Focused

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

  • 12 CPD hours
  • Presented by Paul Sim
  • and Mr Will Burton
  • Next: 10-11 Oct 2022 Live online

The FDA Drug Approval Process

Live online
Focused

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

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

The Medical Device School - From Concept to CE Marking

Live online
Intensive

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

  • 30 CPD hours
  • Presented by Adrian Keene
  • + 7 more
  • Next: on request

The New EU Animal Health Legislation for Veterinary Medicinal Products

Bespoke
Focused

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

  • 12 CPD hours
  • Presented by Dr Julian Braidwood
  • Next: 3 Nov 2022 Live online
  • Also: 3 Mar 2023 Live online
  • Also: 17 Jul 2023 Live online
  • Also: 21 Nov 2023 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

New for 2022

Live online
Focused

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

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

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

New for 2022

Live online
Focused

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

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

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

New for 2022

Live online
Focused

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

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

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2022

Live online
High impact

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

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

Variations to Marketing Authorisations

Live online
Focused

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

  • 12 CPD hours
  • Presented by Joanne Roza
  • and Marloes van der Geer
  • Next: 13-14 Dec 2022 Live online
  • Also: 6-9 Mar 2023 Live online
  • Also: 13-14 Jul 2023 Classroom
  • Also: 12-13 Dec 2023 Live online

Veterinary Pharmaceutical Submissions in the EU

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Andrew Hewitt
  • + 2 more
  • Next: 19-22 Jun 2023 Classroom

Working Through Veterinary Drug Development in the EU and USA

Classroom
Intensive

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

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

Understanding the Pharmaceutical Industry

Self-paced

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

  • Mr John Ansell