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: 15-16 Sep 2022 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
  • and Dr Tamsin Dawson
  • Next: 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: 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: 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: 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: 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: 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
  • 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: 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: 5-6 Oct 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: 19 Jul 2022 Live online
  • Also: 11 Oct 2022 Live online
  • Also: 20 Jan 2023 Classroom

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

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: 5-6 Jul 2022 Live online
  • Also: 18-19 Oct 2022 Live online

EU Pharmaceutical Regulations & Strategy

Live online
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: 22-23 Jun 2022 Live online
  • 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: 11 Jul 2022 Live online
  • Also: 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 Marloes van der Geer
  • Next: 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: 5-6 Jul 2022 Live online
  • Also: 12-13 Oct 2022 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 Mrs Anna Harrington-Morozova
  • 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: 7-8 Jul 2022 Live online
  • Also: 1-2 Dec 2022 Classroom
  • Also: 23-24 Mar 2023 Live online

Medical Device Single Audit Programme (MDSAP)

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: 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.

  • 24 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 30 Jun-1 Jul 2022 Live online
  • Also: 13-14 Oct 2022 Live online

New Regulations for Medical Devices and IVDs in Europe

Live online
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: 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: 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: 24-25 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: 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

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: 14-15 Sep 2022 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 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: 20 Jun 2022 Live online
  • Also: 26 Sep 2022 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 Marloes van der Geer
  • Next: 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: 20-21 Oct 2022 Live online
  • Also: 2-3 Feb 2023 Classroom
  • Also: 1-2 Jun 2023 Live online

Sterilization of Medical Devices

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: 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: 27-28 Jun 2022 Live online
  • Also: 19-20 Sep 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: 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 Mr David Howlett
  • + 7 more
  • Next: 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 Karolina Bate
  • and Dr Mel Munro
  • Next: 13 Jul 2022 Live online
  • Also: 3 Nov 2022 Live online
  • Also: 3 Mar 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 Ms Janette Benaddi
  • 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: 7-8 Jul 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 Andrew Hewitt
  • and Dave Parry
  • Next: 20-24 Jun 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 Andrew Hewitt
  • and David Petrick