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Training courses & Webinars:
Regulatory

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.

 

A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course

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

17-18 Mar 2022 - Online webinar
Also on: 6 Sep 2022

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.

Presented by Tamsin Dawson (bio)
Mel Munro (bio)

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Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

1-2 Mar 2022 - Online webinar
Also on: 27 Sep 2022

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

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)

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An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

23 May 2022 - Online webinar
Also on: 2 Nov 2022

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.

Presented by Theresa Jeary (bio)
David Jefferys (bio)

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An Essential Overview of the Pharmaceutical and Biotech Industries Training Course

An Essential Overview of the Pharmaceutical and Biotech Industries

1 Mar 2022 - Online webinar
Also on: 16 Sep 2022

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

Presented by Laura Brown (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

18-20 May 2022 - Online webinar
Also on: 1 Aug 2022

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.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

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Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

Best Practice for Writing Effective SOPs

27 Jun 2022 - Online webinar
Also on: 19 Sep 2022

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

Presented by Laura Brown (bio)

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Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

8-9 Feb 2022 - London
Also on: 1 Aug 2022

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

Presented by Philip Clay (bio)
Rona Middlemiss (bio)

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Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

16 Jun 2022 - Online webinar
Also on: 1 Dec 2022

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

Presented by Brian Kelly (bio)
David Richardson (bio)
Penny Viner (bio)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

28 Jun 2022 - Online webinar
Also on: 20 Sep 2022

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.

Presented by Laura Brown (bio)

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

30 Mar 2022 - Online webinar
Also on: 5 Oct 2022

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)

Presented by John Price (bio)

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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

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

10-11 Mar 2022 - Online webinar
Also on: 7 Jun 2022

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
and 3 more leading experts

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

11-12 Apr 2022 - Online webinar
Also on: 5 Jul 2022

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.

Presented by Norah Lightowler (bio)

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

23-24 Mar 2022 - Online webinar
Also on: 22 Jun 2022

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.

Presented by Jonathan Hughes (bio)

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Filing eCTD Submissions Training Course

Filing eCTD Submissions

25 Apr 2022 - Online webinar
Also on: 11 Jul 2022

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

Presented by Maikel Bouman (bio)
Marloes van der Geer (bio)

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Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

19-20 May 2022 - Online webinar
Also on: 3 Nov 2022

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.

Presented by Stuart Angell (bio)
Nancy Consterdine (bio)

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

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

12-13 Apr 2022 - Online webinar
Also on: 5 Jul 2022

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.

Presented by Anna Harrington-Morozova (bio)

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Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

15-16 Jun 2022 - Online webinar
Also on: 20 Sep 2022

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

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

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

25-28 Apr 2022 - Online webinar
Also on: 4 Jul 2022

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

Presented by Koen Cobbaert (bio)
Zuzanna Kwade (bio)

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New Regulations for Medical Devices and IVDs in Europe Training Course

New Regulations for Medical Devices and IVDs in Europe

24-25 Feb 2022 - Online webinar
Also on: 13 Oct 2022

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.

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)
David Jefferys (bio)

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

25-26 May 2022 - Online webinar
Also on: 23 Nov 2022

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

Presented by Salma Ismail (bio)
Makram Nehme (bio)

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

20-22 Apr 2022 - Online webinar
Also on: 12 Oct 2022

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

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

25-26 May 2022 - Online webinar
Also on: 22 Nov 2022

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

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

3-4 Feb 2022 - Online webinar
Also on: 15 Aug 2022

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

Presented by Anna Harrington-Morozova (bio)

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Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

29-30 Jun 2022 - Online webinar
Also on: 14 Dec 2022

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

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Registration of Animal Feed Additives in the EU (European Union) Training Course

Registration of Animal Feed Additives in the EU

20-21 Jun 2022 - Online webinar

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Presented by Elinor McCartney (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

28-29 Mar 2022 - Online webinar
Also on: 27 Jun 2022

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.

Presented by Norah Lightowler (bio)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

16 Mar 2022 - Online webinar
Also on: 27 Jun 2022

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

Presented by Marloes van der Geer (bio)

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Risk Management for Pharma and Biopharma Professionals Training Course

Risk Management for Pharma and Biopharma Professionals

29 Apr 2022 - Online webinar
Also on: 14 Oct 2022

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.

Presented by Laura Brown (bio)

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Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course

Technical Documentation to Comply with the MDR and IVDR

25-26 May 2022 - Online webinar
Also on: 22 Nov 2022

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.

Presented by Will Burton (bio)
Paul Sim (bio)

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The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

21-22 Mar 2022 - Online webinar
Also on: 20 Jun 2022

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

Presented by Hans van Bruggen (bio)
Marloes van der Geer (bio)

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The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

13-17 Jun 2022 - Online webinar
Also on: 5 Dec 2022

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.

Presented by Janette Benaddi (bio)

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The New EU (European Union) Animal Health Legislation for Veterinary Medicinal Products Training Course

The New EU Animal Health Legislation for Veterinary Medicinal Products

16-17 May 2022 - Online webinar
Also on: 3 Nov 2022

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.

Presented by Julian Braidwood (bio)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

26-27 Apr 2022 - Online webinar
Also on: 13 Oct 2022

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.

Presented by Marloes van der Geer (bio)

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Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

Veterinary Pharmaceutical Submissions in the EU

9-10 Jun 2022 - Online webinar
Also on: 13 Dec 2022

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.

Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course

Working Through Veterinary Drug Development in the EU and USA

20-24 Jun 2022 - Online webinar
Also on: 5 Dec 2022

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

Presented by David Petrick (bio)

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[Particularly liked]: The speaker and his ability to share the information.
The complex structure of the course.
The workshop prepared for us

Daniel Pepa, Jr. Manager GRA Pharma Vetcare, B. Braun Melsungen AG

I like the course content, the samples presented, and the knowledge application through interactive workshops. Laura is very clear with her topics.

Tiffany Hitchen, Quality Specialist Document Control, Hologic Ltd

Excellent presentation, clear objectives met and well presented.

Andrew Jessup, Compliance Manager, World Transport Agency

Excellent content. Knowledgeable experienced speakers. Lots of practical examples.

David Pickard, Regulatory Manager, Inroads International Ltd

Much more information was provided than I expected, it was VERY useful and well prepared.

Annette Spielbauer, Inoculant Registration and QC Associate, CORTEVA

Very clear and comprehensive presentations.

Kalinka Grozeva, Quality Control Director, Vetagro S.p.A.

I enjoyed the event and even through a virtual platform it was very personable. Overall very happy with the large volume of information provided. My aspirations from the meeting were met as I wanted an overall understanding of the regulations.

Brendan Moran, Technical Director, Hygeia

It was a pleasure to meet Laura Brown. She was very knowledgeable about CAPA and explained in a simple way all the steps to understand the CAPA process.

Oscar Ortego, Export Veterinary Auditor , Food Standards Agency

Good content and examples that are relevant. Speaker provided information that responded to the subject and was well structured. Very good examples.

Ioana Pantelica, GCP Coordinator, Chiesi Canada

during the seminar it was very clear that all speakers have a lot of experience in their fields and I liked the examples, to better understand the process and the time lines

Melanie Wergin, Medical Research Manager, Biologisce Heilmittel Heel GmbH