Our latest COVID-19 information - full Autumn programme of webinars now in place

Training courses & Webinars:
Regulatory

Medical devices in the UK and EU have to undergo a conformity assessment to demonstrate to the regulatory agencies that they meet legal requirements to ensure they are safe and perform as intended. In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with the aim to ensure safety and effectiveness of devices. Our training courses have been designed to provide participants with the necessary information to comply with the regulations in the UK, Europe and the USA.

 

Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

20-21 Apr 2021 - Online webinar
Also on: 22 Apr 2021

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 Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

24-25 May 2021 - Online webinar
Also on: 26 May 2021

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Presented by David Howlett (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

12-14 May 2021 - Online webinar
Also on: 19 May 2021

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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Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

18-19 May 2021 - London
Also on: 23 Nov 2021

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)
Janine Ingleby (bio)

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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

1-2 Dec 2020 - Online webinar
Also on: 8 Jun 2021

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

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Cyber Security for Medical Devices Training Course

Cyber Security for Medical Devices

19-20 Apr 2021 - London
Also on: 21 Apr 2021

Presented by Faysal Boukayoua (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

17-18 Nov 2020 - Online webinar
Also on: 5 May 2021

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Presented by Andrew Willis (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

26-27 Apr 2021 - London
Also on: 28 Apr 2021

Practical guidance on borderline Issues and combination products

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

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Dry Powder Inhalers Training Course

Dry Powder Inhalers

23-24 Jun 2021 - London

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

*FULLY UPDATED PROGRAMME*

Presented by Mike Holroyd (bio)
David Howlett (bio)
Helen Muirhead (bio)

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EC Medical Devices Vigilance System and Post Marketing Surveillance Training Course

EC Medical Devices Vigilance System and Post Marketing Surveillance

26-27 Jan 2021 - Online webinar
Also on: 28 Jan 2021

This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.

Presented by Janette Benaddi (bio)
Grant Castle (bio)
Ekkehard Stosslein (bio)

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

FDA Approval Process for Medical Devices

22-23 Mar 2021 - London
Also on: 24 Mar 2021

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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Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

Human Factors and Usability Engineering in the Development of Drug Delivery Products

23-24 Feb 2021 - Online webinar
Also on: 25 Feb 2021

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Presented by Richard Featherstone (bio)

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Injectable Drug Delivery Training Course

Injectable Drug Delivery

10-11 Mar 2021 - London

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

Presented by Patrick Anquetil (bio)
and 6 more leading experts

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

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

11-12 May 2021 - Online webinar
Also on: 13 May 2021

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

6-7 Oct 2021 - Online webinar
Also on: 13 Oct 2021

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

30 Jun-1 Jul 2021 - Online webinar
Also on: 7 Jul 2021

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 MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

17-19 Nov 2020 - Online webinar
Also on: 28 Apr 2021

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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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

9-10 Nov 2020 - Online webinar
Also on: 10 May 2021

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Presented by Janette Benaddi (bio)
Robin Stephens (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

23-24 Feb 2021 - Online webinar
Also on: 25 Feb 2021

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

16-17 Feb 2021 - Online webinar
Also on: 18 Feb 2021

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presented by David Howlett (bio)

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Nasal Drug Delivery Training Course

Nasal Drug Delivery

15-16 Apr 2021 - London

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Presented by Michael Benninger (bio)
and 13 more leading experts

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New Medical Device Regulation Training Course

New Medical Device Regulation

15-16 Mar 2021 - London
Also on: 17 Mar 2021

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.

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

8-9 Mar 2021 - London
Also on: 10 Mar 2021

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

The Medical Device Summer School - From Concept to CE Marking

5-9 Jul 2021 - London

*A practical five-day course with interactive workshops - now in its 17th successful year!*

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 Nick Baker (bio)
and 8 more leading experts

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The training was PHENOMENAL and I have learned so much regarding various topics in the field.

Anthony Hugill, Clinical Safety Specialist, Novocure

The content was very good, the presentation was comprehensive and the speakers were knowledgeable and confident.

Brigitta Lupsa, Marketed Product Support Team Leader, Owen Mumford Ltd

I learned a lot and got some great insights into the process of design and development. It is an intense course with a lot of ground covered.

Damien Tackney, Reg Affairs, Ovelle Ltd

Janette was very knowledgable and enthusiastic and was able to keep the subjects interesting throughout the whole meeting. The content was very relevant.

Liselotte Borup, Clinical Trial Manager, Oticon Medical

The course gave me a good overview of the MDR and the reporting of adverse events: the content was good, the presentations were clear and the speaker was very good. She was open to questions, which she answered in the best way possible.

Valérie Jean, Senior Clinical Research Associate, Spineart SA

A well set out webinar with plenty of time for questions.

Jenny Lakin, Head of Product Registration, Torbay Pharmaceuticals

A well thought through presentation about a topic that is in flux which gave the current state of play.

David Rose, Medical Quality Expert, Koura

The speakers were clearly very experienced people from the industry and it was a huge privilege to meet them in person. I can definitely say that I know more now than I did three days ago and I can utilize this knowledge in my work. Also, it was good to see and meet other candidates who were from different work background and the challenges they faced.

Pranil Patil, Regulatory Compliance Specialist, Becton Dickinson

Thoroughly enjoyable and highly recommended. This course gave me a great foundation for vigilance and for someone who does not have a vigilance background it was great to learn the basics and the processes. The course was very well organized, there were plenty of opportunities for engagement and the speakers were all very knowledgeable.

Pardeep Kaur Sidhu, Post Market Surveillance Specialist, Quality, BECTON DECKINSON

All the speakers were absolutely excellent. I liked the fact that questions were invited and the chance to clarify with CAs and NB representatives.

Sarah Coverdale, Regulatory Affairs Specialist, Robinson Healthcare Limited