Regulatory Affairs for Support Staff

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.

19-20 Mar 2020

& 29-30 Sep 2020

GBP 1,299
EUR 1,819
USD 2,026

Book now

Course overview

By attending this course you will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market. Pharmacovigilance and safety reporting will be covered as well as licence variations and the commercial aspects of pharmaceutical products. The potential impact of Brexit will also be discussed. The course will provide a thorough grounding in the subject of regulatory affairs and enable you to perform in your role more effectively.

Benefits of attending:

  • Understand the background of EU law – regulations, directives and guidelines
  • Consider the potential impact of Brexit
  • Assess the impact of the EU Clinical Trial Regulation
  • Gain an understanding of the Common Technical Document n Discuss how to apply for a marketing authorisation in the EU – the centralised, decentralised and mutual recognition procedures
  • Clarify post-authorisation obligations – pharmacovigilance, variations and renewals

Who should attend

This course is specifically designed for anyone working in regulatory affairs including personal assistants, secretaries, administrators and any member of support staff wishing to gain a greater understanding of regulatory affairs in the pharmaceutical industry. It is also suitable for those who interface with the regulatory affairs function and who provide support to the regulatory procedures and activities.

Programme - Day one

European Law – Regulations, Directives
  • Impact of Brexit
Where can we find the information on regulatory affairs, approvals, withdrawal?
  • The Internet/publications
  • Approvals and withdrawals
The drug development process
  • Drug discovery
  • Pharmaceutical R&D
  • Non-clinical tests
  • Clinical studies – Phase I to IV
  • Registration

CASE STUDY 1

  • The EU Clinical Trials Directive and new Clinical Trial Regulation*
  • What is the process for running clinical trials in Europe?
Seeking scientific advice in Europe
  • What are the processes?
The Common Technical Document
  • Structure and content of a CTD
The European Medicines Agency
  • Impact of Brexit

Impact of Brexit

Programme - Day two

Applying for a Marketing Authorisation in the EU with discussion on the impact of Brexit
  • The EU centralised procedure
  • Decentralised procedure
  • Mutual recognition procedure
  • National procedures

CASE STUDY 2

Generic applications
  • Requirements
Parallel trade
  • How the process works
  • Impact of Bexit
Managing product labelling
  • Company core data sheets
  • Updates to Summary of Product Characteristics

Post-authorisation obligations; pharmacovigilance, variations and renewals including discussion on the impact of Brexit

Pharmacovigilance and GCP inspections

Licence variations
  • Type I and Type II variations
  • Procedures and timelines

CASE STUDY 3

Renewals

Managing and supporting a regulatory affairs department
  • Things to consider
  • Maintaining oversight

Presenter

Norah Lightowler

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.

Book now

19-20 Mar 2020
19-20 Mar 2020 Holiday Inn London - Kensington Forum, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
+ VAT @ 20.00%
Enrol now
29-30 Sep 2020
29-30 Sep 2020 Rembrandt Hotel, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Abbott Products Operations AG
  • Abbvie Ltd.
  • Abbvie Srl
  • Allergan Ltd
  • Almirall Ltd
  • Almus Pharmaceuticals Ltd
  • Bayer Consumer Care AG
  • BRISTOL-MYERS SQUIBB KFT
  • Celgene Europe Ltd
  • European Medicines Agency
  • F. Hoffmann-La Roche
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • Glenmark Pharmaceuticals Europe Limited
  • Johnson & Johnson
  • Johnson and Johnson
  • Merck Serono SA
  • Mundipharma Research
  • Mundipharma Research Limited
  • Mylan Pharma UK Ltd
  • NDA Regulatory Science Ltd
  • Nutriad International BV
  • PAREXEL Consulting
  • Patheon UK Ltd
  • Pfizer
  • SCHWARZ PHARMA LTD
  • Targovax ASA
  • Teva UK Ltd
  • Trilogy Writing & Consulting GmbH
  • Weifa AS

Highly recommended course for anyone wishing to learn more about their involvement within the regulatory affairs team at your particular company. The speaker, Norah, was very effective in her presentations and included each delegate and was able to highlight how certain areas were specific to them.

James Smith, Regulatory Affairs Officer, Kyowa Kirin International

I spent a nice moment, and I come back with a lot of information, which is very motivating for my job.

Audrey Chopard-Lallier, Administrative Assistant, Debiopharm International SA

[The speakers were] very knowledgable.

Therese Metzsch, Senior Assistant, Ferring Pharmaceuticals A/S

Madam Norah Lightowler is an excellent speaker... Presentation was great, everything was clear. The speaker was really nice and she gave a great input about this whole industry and RA.

Valentina Cabula, eCTD Specialist, Xellia Pharmaceuticals ApS

Norah [the speaker] is a very nice and professional person

Sarah Bourgin, Associate Regulatory Affairs Specialist, Medtronic BioPharma Sàrl

Very thorough run-through of all RA procedures and on-going maintenance

Elliot Statham, Business Development Specialist, Creo Pharma Ltd.

The course, presentation and speaker were all brilliant

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

Useful course to get a broader knowledge and insight about the position of the RA associate.

Dusan Ilic, RA Associate, Mallinckrodt Medical BV

Interesting and informative. Good speaker, very knowledgable.

Marissa Ashfield, Pharmacovigilance - AO, Veterinary Medicines Directorate

Very interesting content and well explained by speaker

Charlotte Sellwood, Regulatory Information Executive, Bayer PLC

All very good

Karen Scott, Regulatory Affairs Team Administrator, Mundipharma Research Limited

The facilities and the event organisers were very good, really welcoming and polite. The venue was a great choice and the refreshments offering was great! Thank you!

Daniel Akhtar, RA Business Support Specialist, Abbvie Ltd.

The course was detailed and interesting. I found the speaker to be engaging and friendly.

Bethan Farley, Regulatory Conformance Manager, Norgine Ltd

I like the content and also the presentation of the slides. Norah was a very pleasure person to explain and clear in everything she was saying.

Barbara Costa, Regulatory Affairs Assistant, Glenmark Pharmaceuticals Europe Limited

Very informative

Roshini Nellailingam, Regulatory Affairs Manager, Emas Pharma Ltd

I would definitely recommend the course for people with very basic knowledge on Regulatory Affairs in Europe. All expected topics were covered sufficiently (even some global regulatory topics). Norah was very clear and happy to answer questions.

Beata Posa, Access to Documents Coordinator, EMEA

It was a good material, well present and I enjoy the discussions about the context

Barbara Costa, Regulatory Affairs Assistant, Glenmark Pharmaceuticals Europe Limited

As someone who has no experience of what the course included, I was able to make some sense in relation to documents that my colleagues write

Joanne Zaninovic, Client Account Assistant, Trilogy Writing & Consulting GmbH

Very useful and enjoyable

Hannah Lee, Regulatory Affairs Student Placement, Mundipharma Research Limited

The content was packed with relevant information leaving me confident in my role

Christina Obafemi, Regulatory Affairs Specialist II, Teva UK Limited

Good introductory course. Good presentation by a knowledgeable speaker. Interactive case study sessions. Pleasant environment.

Edouard Guillabert, Director & Consultant, GalenAuxi Ltd

Interesting and very enjoyable

Rupinder (Ruby) Bhelay, PA/Team Administrative Assistant - Regulatory Affairs & Quality, Baxalta UK Ltd – now part of Shire Pharmaceuticals (4th Floor)