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

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.

 

An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

12 Oct 2020 - Online webinar
Also on: 13 May 2021

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

23 Oct 2020 - Online webinar
Also on: 26 Oct 2020

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 Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

22-23 Sep 2020 - Online webinar
Also on: 15 Mar 2021

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Presented by Chris Penfold (bio)

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Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

10 Dec 2020 - London
Also on: 11 Dec 2020

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

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

30 Mar 2021 - Online webinar
Also on: 31 Mar 2021

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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Common Technical Document Training Course

Common Technical Document

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

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Presented by Andrew Willis (bio)

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Cyber Security for Medical Devices Training Course

Cyber Security for Medical Devices

5-6 Nov 2020 - Online webinar
Also on: 19 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

22-23 Sep 2020 - London
Also on: 24 Sep 2020

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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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

24 Sep 2020 - Online webinar
Also on: 11 Feb 2021

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

22-23 Oct 2020 - Online webinar
Also on: 29 Oct 2020

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations

Presented by Norah Lightowler (bio)

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Filing eCTD Submissions Training Course

Filing eCTD Submissions

12 Apr 2021 - London
Also on: 13 Apr 2021

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

Presented by Justin Bailey (bio)
Jasbir Chohan (bio)

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How to Write Effective SOPs (Standard Operating Procedures) Training Course

How to Write Effective SOPs

3 Dec 2020 - Online webinar
Also on: 28 Jun 2021

An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.

Presented by Laura Brown (bio)

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Improving Processes and CAPA (Corrective and Preventative Action) Training Course

Improving Processes and CAPA (Corrective and Preventative Action)

4 Dec 2020 - Online webinar
Also on: 29 Jun 2021

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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Inhaled Drug Delivery Training Course

Inhaled Drug Delivery

3-4 Nov 2020 - London

An essential annual update for inhalation professionals.

Presented by Mike Holroyd (bio)
David Howlett (bio)
Helen Muirhead (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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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

16-17 Sep 2020 - Online webinar
Also on: 16 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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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

5-6 Oct 2020 - Online webinar
Also on: 12 Oct 2020

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Presented by Andrew Willis (bio)
Alison Wilson (bio)

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Pharmaceutical Packaging, Labelling and Artwork Origination Training Course

Pharmaceutical Packaging, Labelling and Artwork Origination

28-29 Oct 2020 - London
Also on: 27 Oct 2021

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

Presented by George Barrie (bio)
and 7 more leading experts

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

12-13 Oct 2020 - Online webinar
Also on: 22 Mar 2021

Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe and French-speaking Africa

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

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

7-9 Apr 2021 - Online webinar
Also on: 14 Apr 2021

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

23-24 Nov 2020 - Basel
Also on: 25 Nov 2020

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

2-3 Feb 2021 - London
Also on: 4 Feb 2021

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

28-29 Jun 2021 - Online webinar
Also on: 5 Jul 2021

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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Process Validation with Qualification Training Course

Process Validation with Qualification

22-23 Sep 2020 - Online webinar
Also on: 2 Mar 2021

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Presented by Bruce Davis (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

29-30 Sep 2020 - Online webinar
Also on: 16 Mar 2021

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

23 Sep 2020 - Online webinar
Also on: 10 Mar 2021

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

Presented by Andrew Willis (bio)

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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

2-3 Dec 2020 - Online webinar
Also on: 6 Jul 2021

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Presented by Ray Munden (bio)
Allan Watkinson (bio)

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

The FDA Drug Approval Process

21-22 Sep 2020 - Online webinar
Also on: 28 Sep 2020

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

Presented by Andrew Willis (bio)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

8-9 Oct 2020 - Online webinar
Also on: 25 Mar 2021

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 Andrew Willis (bio)

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I was hoping to get a better insight into writing reports and I would say that I definitely believe this was accomplished.

Neil McCann, Radiation Safety Officer, Elekta Limited

Barbara was technically brilliant and presented in a fun, challenging and friendly way. The content through the day was very useful, with good pointers and tips to improve the layout and quality of documents. The course structure and content was excellent, a good amount for a day's course. The presentation was fantastic and easy to follow with good exercises and interaction between presenter and course participants. Barbara has a deep knowledge of the subject matter which is delivered in an exciting way.

Nathan Entwistle, Senior Electronics Technician, Team Consulting

Very good course with plenty of personal interaction. The experience of the speaker gives added value as she can provide many examples and tips and tricks for reviewing a text.

Anke De Muylder, Quality engineer QA, Plasma Industries Belgium

Excellent presentation by a first-class speaker who has a wealth of knowledge. I particularly liked the interactive exercises.

Wil Pantin, New Product Introduction Manager, M & A Pharmachem Ltd

Overall the course content was very good. Presentation was also good and very clear. The speaker was excellent and very active during the training.

Ildephonse Ngabonziza, Clinical Safety Manager, Genae Associates NV

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

A really good and useful course. The speakers are obviously experts in their fields and are very good at communicating their knowledge.

Miriam Ferrer, Head of New Product Development, Cambridge Nutraceuticals

Very worthwhile course with a great mix of experts.

Stephanie Ward, Marketing Executive, Cambridge Nutraceuticals

A good course.

Konstantina Karagkika, Technical Manager, Innocent Drinks