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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

& 30-31 Jan 2023 , 9-10 May 2023 , 26-29 Sep 2023

Book or reserve now

Details

Course overview

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

This interactive course is designed for those working in a support 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 the UK will be discussed.

The programme covers 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
  • 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
  • Discussion of the impact of Brexit

Who should attend?

This course is designed for personnel working in regulatory affairs including administrators, assistants and support staff wishing to gain an understanding of regulatory affairs in the pharmaceutical industry.

It will also be of value to those who interface with the regulatory affairs function or support the regulatory procedures and activities.

Programme

European law – regulations, directives and guidelines

  • Different legal force

Where can we find information on regulatory requirements?

  • The internet
  • Other sources

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

  • 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 and in the UK

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

Abridged Applications and Generics

  • Types and requirements

Product Life Cycle; Post approval

Parallel trade

  • How the process works

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

Pharmacovigilance

  • 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.

Book now

Book or reserve now

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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
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
30-31 Jan 2023
Live webinar
09:15-17:00
UK (London)
30-31 Jan 2023
Live webinar
09:15-17:00
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 26 Dec*
Enrol now
to attend Live webinar
9-10 May 2023
Face-to-face, Rembrandt Hotel London
9-10 May 2023
Face-to-face
Rembrandt Hotel London
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 4 Apr 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
26-29 Sep 2023
Live webinar
13:30-16:30
UK (London)
26-29 Sep 2023
Live webinar
13:30-16:30
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 22 Aug 23*
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...

  • Actelion Pharmaceuticals Ltd
  • Actelion Pharmaceuticals Ltd.
  • Alexion Pharma EMEA GmbH
  • Almirall Ltd
  • BRISTOL MYERS SQUIBB
  • Camurus AB
  • Celgene Kft
  • Chiesi Farmaceutici SPA
  • F. Hoffmann-La Roche
  • Gilead Sciences International Ltd
  • Indivior UK Limited
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Johnson and Johnson
  • Kyowa Kirin Limited
  • Mallinckrodt Medical B.V.
  • Merial Animal Health Ltd
  • Mundipharma Research Limited
  • Norgine Ltd
  • Novo Nordisk A/S
  • Nutriad International BV
  • PAREXEL Consulting
  • Patheon UK Ltd
  • Pfizer Limited
  • Prostrakan
  • Sanofi-Aventis
  • SCHWARZ PHARMA LTD
  • Shire Pharmaceutical Ltd
  • Teva UK Ltd
  • Trilogy Writing GmbH
  • Xellia Pharmaceuticals ApS

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