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Regulatory Affairs for Support Staff Training Course

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.

27-28 Sep 2022

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Details

Course overview

Working in pharmaceutical regulatory affairs is a complex role, with involvement in the drug development stages to post-approval obligations and marketing.

This interactive course is designed for those working in a support staff role and 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 the EU and the regulatory activities that need to be complied with to keep products on the market. The impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical market in Great Britain and Northern Ireland will be discussed.

The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the impact of Brexit in these areas. 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
  • Discussion of the impact of Brexit
  • Gain an understanding of the Common Technical Document
  • Discuss how to apply for a marketing authorisation in the EU via the centralised, decentralised and mutual recognition procedures
  • Clarify post-authorisation obligations – pharmacovigilance, variations and renewals
  • Assess the impact of the EU Clinical Trials 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 will also be of value to those who interface with the regulatory affairs function or provide support to the regulatory procedures and activities.

Programme

European law – regulations, directives and guidelines

  • Impact of Brexit

Where can we find information on regulatory requirements?

  • The internet
  • Approvals and withdrawals

The drug development process

  • Drug discovery
  • Pharmaceutical R&D
  • Non-clinical tests
  • Clinical studies – Phase I to IV

Clinical Trials in Europe

  • The EU clinical Trials Regulation
  • Clinical trials in the UK

Seeking scientific advice in Europe

  • Outline of procedures

Types of and categories for marketing authorisation of applications for approval

The CTD

  • Overview of the structure and content of a CTD

The European Medicines Agency

  • Functions and responsibility

Procedures for marketing authorisation in the EU with discussion on the impact of Brexit

The EU centralised procedures

  • EU centralised procedure for marketing authorisation
  • Referral and arbitration

Non-centralised procedures for marketing authorisation in the EU with discussion on the impact of Brexit

  • Co-ordination group
  • Decentralised procedure
  • Mutual recognition procedure
  • National procedures

Generic applications

  • Types and requirements

Product Life Cycle; Post approval

Parallel trade

  • How the process works
  • Impact of Brexit

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

Pharmacovigilance and GCP inspections including discussion on the impact of Brexit

  • Requirements and criteria

Licence variations

  • Types and timelines

Extensions

Renewals

Sunset clause

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.

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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
27-28 Sep 2022
Live webinar
09:15-17:00
UK (London)
27-28 Sep 2022
Live webinar
09:15-17:00
UK (London)
GBP 1,099 899
EUR 1,579 1,299
USD 1,786 1,474
Until 23 Aug*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbvie Srl
  • Actelion Pharmaceuticals Ltd.
  • Alcon
  • Ares Trading SA
  • Azelis UK Ltd
  • Bayer Consumer Care AG
  • BioMarin Europe Ltd
  • Boehringer Ingelheim Animal Health GmbH
  • Bray Group Ltd
  • Chiesi Farmaceutici SPA
  • Delaval NV
  • F. Hoffmann-La Roche Ltd
  • Fisher Clinical Services
  • GALDERMA Recherche & Developpement
  • Gilead Sciences International
  • Glaxo Smith Klein
  • Glenmark Pharmaceuticals Europe R&D Ltd
  • GSK Consumer Healthcare
  • Indivior UK Limited
  • Kyowa Kirin Limited
  • Mallinckrodt Medical BV
  • Merial Animal Health Ltd
  • Norgine Ltd
  • Pfizer
  • Pfizer Limited
  • Sanofi
  • SCHWARZ PHARMA LTD
  • TMC Pharma Services Ltd
  • United Therapeutics Europe Ltd
  • Xellia Pharmaceuticals AsP

A lot of information was provided. It is now up to us to dig a bit further the different areas. Speaker was a great professional in Regulatory Affairs. As a new comer in this area, I found it sometimes difficult to cope with all abbreviations (though the course included a glossary, it takes time to go back to it and in the meanwhile the training has moved forward). I am satisfied with this training.

Karin GEROLA, Regulatory Affairs Compliance Manager, GSK Consumer Healthcare, Sep 20

I was a bit worried about not having a face-to-face course and discussions but it worked very well, it was really comfortable to do it from my home and we had no major connectivity issues.

Viktoria Vanyik, Global Regulatory Affairs, Compliance Associate, GSK, Sep 20

Great speaker.

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

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

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

[The speakers were] very knowledgable.

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

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

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

Interesting and informative. Good speaker, very knowledgable.

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

The course, presentation and speaker were all brilliant

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

Very interesting content and well explained by speaker

Charlotte Sellwood, Regulatory Information Executive, Bayer PLC, 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

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

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

All very good

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