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Regulatory Affairs for Support Staff Training Course: face to face & live 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.

29-30 Sep 2020

& 18-19 Mar 2021 , 27-28 Sep 2021

Book now

Course overview

Working in pharmaceutical regulatory affairs is a complex role, with involvement in not only the drug development stages but also post drug-approval activities and marketing.

This interactive course, designed specifically for those working in a support staff role, provides a valuable introduction to pharmaceutical regulatory affairs and key responsibilities.

Participants will gain an overview of the 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.

The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the potential impact of Brexit. The course will provide a thorough grounding in the subject of regulatory affairs and enable support staff to perform more effectively.

Discussion sessions and the use of case studies throughout the two days will help consolidate learning.

Benefits of attending:

  • Understand the background of EU law – regulations, directives and guidelines
  • Consider the potential impact of Brexit
  • 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
  • Assess the impact of the EU Clinical Trial Regulation

Who should attend

This course is designed for anyone working in regulatory affairs including administrators, assistants 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 provide support to the regulatory procedures and activities.

Programme - day 1

European law – regulations, directives and guidelines

  • Impact of Brexit

Where can we find information on regulatory affairs?

  • 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

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 CTD

  • Structure and content of a CTD

The European Medicines Agency

  • Impact of Brexit

Programme - day 2

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

Generic applications

  • Requirements

Parallel trade

  • How the process works
  • Impact of Brexit

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

  • What to expect

Licence variations

  • Type I and Type II variations
  • Procedures and timelines

Renewals

Managing and supporting a regulatory affairs department

  • Things to consider
  • Maintaining oversight

Presenter

Norah Lightowler (More...)

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

  attend Face to face attend Live webinar
29-30 Sep 2020, Rembrandt Hotel, London
29-30 Sep 2020 Rembrandt Hotel, London GBP 1,099.00
EUR 1,539.00
USD 1,714.00
Until 18 Aug*
Enrol now
to attend
Face to face
GBP 899.00
EUR 1,299.00
USD 1,474.00
Until 18 Aug*
Enrol now
to attend
Live webinar
18-19 Mar 2021, Venue not yet confirmed
18-19 Mar 2021 Venue not yet confirmed GBP 1,099.00
EUR 1,539.00
USD 1,714.00
Until 4 Feb 21*
Enrol now
to attend
Face to face
GBP 899.00
EUR 1,299.00
USD 1,474.00
Until 4 Feb 21*
Enrol now
to attend
Live webinar
27-28 Sep 2021, Venue not yet confirmed
27-28 Sep 2021 Venue not yet confirmed GBP 1,099.00
EUR 1,539.00
USD 1,714.00
Until 16 Aug 21*
Enrol now
to attend
Face to face
GBP 899.00
EUR 1,299.00
USD 1,474.00
Until 16 Aug 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Abbott Products Operations AG
  • Abbvie Srl
  • Achenyo Ochuma
  • Actelion Pharmaceutical Ltd
  • Actelion Pharmaceuticals Ltd.
  • Air Products plc
  • Allergan Ltd
  • Aptar Pharma
  • Azad Pharma AG
  • BD Medical – Pharmaceutical Systems
  • Bray Group Ltd
  • Dafra Pharma International
  • Evonik Industries AG
  • Galderma SA
  • Gilead Sciences
  • Gilead Sciences International Ltd
  • GIS EUROPE S.E.
  • Ipsen Biopharm Ltd
  • Johnson & Johnson
  • Medtronic BioPharma Sàrl
  • Merck Serono Ltd
  • Merial Animal Health Ltd
  • Mylan Pharma UK Ltd
  • Novella Clinical, a Quintiles Company
  • Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Warsaw
  • Pfizer Limited
  • RTE
  • Sanofi Pasteur SA
  • Takeda GmbH
  • Weifa AS

Great speaker.

Ena Mrakužić, Public Relations Associate, Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Sep 19

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, Mar 19

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 , Mar 19

[The speakers were] very knowledgable.

Therese Metzsch, Senior Assistant, Ferring Pharmaceuticals A/S, Sep 18

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, Sep 18

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

Sarah Bourgin, Associate Regulatory Affairs Specialist, Medtronic BioPharma Sàrl, Sep 18

Very interesting content and well explained by speaker

Charlotte Sellwood, Regulatory Information Executive, Bayer PLC, Feb 18

The course, presentation and speaker were all brilliant

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate, Feb 18

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

Elliot Statham, Business Development Specialist, Creo Pharma Ltd., Feb 18

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

Dusan Ilic, RA Associate, Mallinckrodt Medical BV, Feb 18

Interesting and informative. Good speaker, very knowledgable.

Marissa Ashfield, Pharmacovigilance - AO, Veterinary Medicines Directorate, Feb 18

All very good

Karen Scott, Regulatory Affairs Team Administrator, Mundipharma Research Limited, Sep 17

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., Sep 17

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

Bethan Farley, Regulatory Conformance Manager, Norgine Ltd, Feb 17

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, Oct 16