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.

14-15 Mar 2019

& 23-24 Sep 2019

GBP 1,299 1,099 *
EUR 1,819 1,539 *
USD 2,026 1,714 *
* When you book before 21 Jan

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

Book now

14-15 Mar 2019
14-15 Mar 2019 Rembrandt Hotel, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
+ VAT @ 20.00%
GBP 1,099.00
EUR 1,539.00
USD 1,714.00
Until 21 Jan
Enrol now
23-24 Sep 2019
23-24 Sep 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Allergan Pharmaceuticals International Ltd
  • Air Products plc
  • Alcon
  • Almirall Ltd
  • Astellas Pharma Ltd
  • Boehringer Ingelheim Pharma
  • Delaval NV
  • Eli Lilly & Company Ltd
  • Emas Pharma Ltd
  • ENTERPRISE IRELAND
  • Ewopharma International, s.r.o.
  • F. Hoffmann-La Roche Ltd
  • Galderma R&D
  • GALDERMA Recherche & Developpement
  • Gilead Sciences International Ltd
  • Hoffman La Roche
  • Ipsen Biopharm Ltd
  • Mundipharma Research
  • Naturex SA
  • Novo Nordisk A/S
  • Parapharm Development LTD
  • Pliva Croatia Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Research and Markets
  • SCHWARZ PHARMA LTD
  • Shire Pharmaceutical Ltd
  • Teva UK Ltd
  • Weifa AS
  • Wockhardt (UK) Ltd
  • Xellia Pharmaceuticals ApS

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

[The speakers were] very knowledgable.

Therese Metzsch, Senior Assistant, Ferring Pharmaceuticals A/S

Very interesting content and well explained by speaker

Charlotte Sellwood, Regulatory Information Executive, Bayer PLC

Interesting and informative. Good speaker, very knowledgable.

Marissa Ashfield, Pharmacovigilance - AO, 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

The course, presentation and speaker were all brilliant

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

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

Elliot Statham, Business Development Specialist, Creo Pharma Ltd.

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, Product Specialist - Global Technical Management, Norgine Ltd

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

Christina Obafemi, Regulatory Affairs Specialist II, Teva UK Limited

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

Very useful and enjoyable

Hannah Lee, Regulatory Affairs Student Placement, Mundipharma Research 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

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

Barbara Costa, Regulatory Affairs Assistant, Glenmark Pharmaceuticals Europe Limited

Interesting and very enjoyable

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

Very informative

Roshini Nellailingam, Regulatory Affairs Manager, Emas Pharma Ltd

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

Edouard Guillabert, Director & Consultant, GalenAuxi 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