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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

15-16 Sep 2022 - London

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

27-28 Sep 2022 - Online webinar

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

2 Nov 2022 - Online webinar

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

16 Sep 2022 - Online webinar

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

1-3 Aug 2022 - London
Also on: 8 Nov 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

19 Sep 2022 - London
Also on: 12 Dec 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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Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

1 Dec 2022 - Online webinar

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)
Penny Viner (bio)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

20 Sep 2022 - London
Also on: 13 Dec 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

5-6 Oct 2022 - Online webinar

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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Cyber Security for Medical Devices Training Course

Cyber Security for Medical Devices

19 Jul 2022 - Online webinar
Also on: 11 Oct 2022

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.

Presented by Ben Kokx (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

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

18-19 Oct 2022 - Online webinar

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.

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

12-13 Sep 2022 - Online webinar
Also on: 5 Dec 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

19 Oct 2022 - Online webinar

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)

3-4 Nov 2022 - Online webinar

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

5-6 Jul 2022 - Online webinar
Also on: 12 Oct 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

20-21 Sep 2022 - London
Also on: 7 Dec 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 Single Audit Programme (MDSAP) Training Course

Medical Device Single Audit Programme (MDSAP)

1-2 Dec 2022 - London
Also on: 23 Mar 2023

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.

Presented by Eamonn Hoxey (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

18-21 Oct 2022 - Online webinar

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

13-14 Oct 2022 - Online webinar

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

23-24 Nov 2022 - Online webinar

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

12-14 Oct 2022 - Online webinar

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

22-23 Nov 2022 - Online webinar

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

15-16 Aug 2022 - Online webinar

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 Veterinary Vaccines in the USA and Canada Training Course

Registration of Veterinary Vaccines in the USA and Canada

14-15 Sep 2022 - Online webinar

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.

Presented by Nick Wills (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

27-28 Sep 2022 - Online webinar

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

26 Sep 2022 - Online webinar

This must-attend 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

14 Oct 2022 - Online webinar

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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Sterilization of Medical Devices Training Course

Sterilization of Medical Devices

20-21 Oct 2022 - Online webinar
Also on: 2 Feb 2023

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.

Presented by Eamonn Hoxey (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

22-23 Nov 2022 - Online webinar

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

19-20 Sep 2022 - Online webinar

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

5-9 Dec 2022 - Online webinar

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

3-4 Nov 2022 - Online webinar

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 Karolina Bate (bio)
Mel Munro (bio)

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UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course

UK Conformity Assessed (UKCA) Marking for Medical Devices

13 Jul 2022 - Online webinar
Also on: 3 Nov 2022

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.

Presented by Janette Benaddi (bio)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

7-8 Jul 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 Joanne Roza (bio)
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

13-14 Dec 2022 - Online webinar

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.

Presented by Andrew Hewitt (bio)
Colin McLean (bio)
Dave Parry (bio)

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

Working Through Veterinary Drug Development in the EU and USA

12-16 Sep 2022 - Online webinar

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

Presented by Andrew Hewitt (bio)
David Petrick (bio)

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Absolutely fantastic. I needed to be able to communicate more effectively with my Regulatory colleagues and I believe the information I have learned on this course will assist me to do that

Jenny Ramsey, Quality Engineer - Compliance, Pfizer R&D UK Ltd

My intent was to get an overall picture of the lay out of a vaccine registration dossier, content and submission timelines. Thanks to the extensive course, I got a full and complete tool box... the webinar has been very enjoyable, informative. Congratulations to both speakers because It is not an easy exercise when addressing attendants through screens.

Frédérique Cernicchiaro, Specialiste Pharmacovigilance Globale, Boehringer Ingelheim

My intent was to get an overall picture of the lay out of a vaccine registration dossier, content and submission timelines. Thanks to the extensive course, I got a full and complete tool box.

Frédérique Cernicchiaro, Specialiste Pharmacovigilance Globale, Boehringer Ingelheim

Excellent would attend other similar webinar/trainings

Cheryl Dicks, Sr. Mgr. Regulatory, CANbridge Pharmaceuticals

All was great, no complaints!

Angelica Morreno, Regulatory Affairs Assistant, Sinclair Pharmaceuticals

I was hoping to get more information regarding 510(k) submissions. I am very happy that I got the opportunity to learn much more. I learned a lot and feel more confident about my understanding of the submission processes.

Natale Rolim, Project Manager, EpiGuard

I was happy to attend to this webinar and it was really useful and well-explained and organized.

Mireia Crosa, Regulatory and Compliance Specialist, Diagnostic Grifols, S.A.

I think it was especially helpful for the slightly advanced in these areas.

Ladislav Pazout, Production director, DYNTEC, spol. s r. o.

Excellent - speakers were very, very knowledgeable, kept things interesting, lots of opportunity for questions..

Róisín Byrne, Senior Regulatory Affairs Officer, Ayrton Saunders Limited

I did get some interesting information that may be useful when writing these documents in the future.

Nele Hilgert, Medical Writer, Emtex Life Science