Presented by
Management Forum

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.

28-29 Mar 2022 + 2 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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.

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The Regulatory Affairs for Support Staff course will cover:

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

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?

Types and categories of applications for approval

The CTD

  • Structure and content of a CTD

The European Medicines Agency

  • Impact of Brexit

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

  • The EU centralised procedure

EU centralised procedures

Referral and arbitration


Applying for a marketing authorisation in the EU with discussion on the impact of Brexit (cont.)

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

Generic applications

  • 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

  • What to expect

Pharmacovigilance and GCP inspections including discussion on the impact of Brexit

  • What to expect

Licence variations

  • Type I and Type II variations
  • Procedures and timelines

Extensions

Renewals

Sunset clause

Managing and supporting a regulatory affairs department

  • Things to consider
  • Maintaining oversight

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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.

More details

Book Regulatory Affairs for Support Staff Live online/Classroom training

28-29 Mar 2022

Live online

09:15-17:00 UK (London) (UTC+01)
10:15-18:00 Paris (UTC+02)
04:15-12:00 New York (UTC-04)
Course code 11582

  • GBP 899 1,099
  • EUR 1,299 1,579
  • USD 1,474 1,786

Until 21 Feb

In your basket 

27-28 Jun 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11931

  • GBP 1,099 1,299
  • EUR 1,539 1,819
  • USD 1,714 2,026

Until 23 May

  • 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

In your basket 

27-28 Sep 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11703

  • GBP 899 1,099
  • EUR 1,299 1,579
  • USD 1,474 1,786

Until 23 Aug

In your basket 

Reviews of IPI's Regulatory Affairs for Support Staff training course


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.

Sep 29 2020

Viktoria Vanyik
Global Regulatory Affairs, Compliance Associate, GSK

Sep 29 2020

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

Mar 14 2019

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

Sep 23 2019

Great speaker

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

Sep 23 2019

Great speaker.

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

Mar 14 2019

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

Sep 20 2018

[The speakers were] very knowledgable.

Therese Metzsch
Senior Assistant, Ferring Pharmaceuticals A/S

Sep 20 2018

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

Feb 22 2018

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

Elliot Statham
Business Development Specialist, Creo Pharma Ltd.

Feb 22 2018

Very interesting content and well explained by speaker

Charlotte Sellwood
Regulatory Information Executive, Bayer PLC

Feb 22 2018

The course, presentation and speaker were all brilliant

Jamie Jardine
Administrative Officer, Veterinary Medicines Directorate

Feb 22 2018

Interesting and informative. Good speaker, very knowledgable.

Marissa Ashfield
Pharmacovigilance - AO, Veterinary Medicines Directorate

Sep 20 2018

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

Sarah Bourgin
Associate Regulatory Affairs Specialist, Medtronic BioPharma Sàrl

Feb 22 2018

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

Dusan Ilic
RA Associate, Mallinckrodt Medical BV

Sep 28 2017

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 28 2017

All very good

Karen Scott
Regulatory Affairs Team Administrator, Mundipharma Research Limited

Feb 27 2017

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

Bethan Farley
Regulatory Conformance Manager, Norgine Ltd

Oct 17 2016

Interesting and very enjoyable

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

Oct 17 2016

Very informative

Roshini Nellailingam
Regulatory Affairs Manager, Emas Pharma Ltd

Oct 17 2016

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

Barbara Costa
Regulatory Affairs Assistant, Glenmark Pharmaceuticals Europe Limited

Oct 17 2016

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

Christina Obafemi
Regulatory Affairs Specialist II, Teva UK Limited

Oct 17 2016

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

Oct 17 2016

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

Oct 17 2016

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 17 2016

Very useful and enjoyable

Hannah Lee
Regulatory Affairs Student Placement, Mundipharma Research Limited

Oct 17 2016

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

Edouard Guillabert
Director & Consultant, GalenAuxi Ltd

UK

  • Abbvie Ltd.
  • Achenyo Ochuma
  • Air Products plc
  • Alcon
  • Allergan UK Limited
  • Almirall Ltd
  • Almus
  • Almus Pharmaceuticals Ltd
  • Astellas Pharma Ltd
  • Azelis UK Ltd
  • BAUSCH & LOMB INC
  • Baxalta UK Ltd – now part of Shire Pharmaceuticals (4th Floor)
  • Bayer PLC
  • BioMarin Europe Ltd
  • Bray Group Ltd
  • BRISTOL MYERS SQUIBB
  • Celgene Europe Ltd
  • Creo Pharma Ltd.
  • Danisco A/S
  • Eli Lilly & Company Ltd
  • Emas Pharma Ltd
  • EMEA
  • European Medicines Agency
  • Fisher Clinical Services
  • GalenAuxi Ltd
  • Gilead Sciences
  • Gilead Sciences International
  • Gilead Sciences International Ltd
  • Glaxo Smith Klein
  • Glaxo SmithKline
  • GlaxoSmithKline
  • Glenmark Pharmaceuticals Europe Limited
  • Glenmark Pharmaceuticals Europe R&D Ltd
  • GSK Consumer healthcare
  • GSK Consumer Healthcare (UK) Ltd
  • Indivior UK Limited
  • Ipsen Biopharm Ltd
  • Johnson & Johnson Limited
  • Johnson & Johnson Ltd
  • Johnson and Johnson
  • Kyowa Kirin International
  • Kyowa Kirin Limited
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Merck Serono Ltd
  • Merial Animal Health Ltd
  • Mundipharma Research
  • Mundipharma Research Limited
  • Mundipharma Research Ltd
  • Mylan
  • Mylan Pharma UK Ltd
  • NDA Regulatory Science Ltd
  • Norgine Limited
  • Norgine LTD
  • Novella Clinical, a Quintiles Company
  • Parapharm Development LTD
  • PAREXEL Consulting
  • Patheon UK Ltd
  • Prostrakan
  • Reckitt Benckiser Healthcare (UK) Ltd
  • RWS Group
  • Sanofi-Aventis
  • SCHWARZ PHARMA LTD
  • Shire Pharmaceutical Ltd
  • TEVA Pharmaceuticals Europe BV
  • Teva UK Limited
  • Teva UK Ltd
  • TMC Pharma Services Ltd
  • United Therapeutics Europe Ltd
  • Veterinary Medicines Directorate
  • Walgreens Boots Alliance Services Limited
  • Wockhardt (UK) Ltd

Switzerland

  • Abbott Products Operations AG
  • Actelion Pharmaceutical Ltd
  • Actelion Pharmaceuticals Ltd
  • Actelion Pharmaceuticals Ltd.
  • Alexion Pharma EMEA GmbH
  • Ares Trading SA
  • Azad Pharma AG
  • AZAD Pharmaceutical Ingrediant AG
  • BAXTER HEALTHCARE SA
  • Bayer Consumer Care AG
  • Debiopharm International SA
  • F. Hoffmann-La Roche
  • F. Hoffmann-La Roche Ltd
  • Galderma SA
  • GSK
  • GSK Consumer Healthcare
  • Hoffmann-La Roche
  • Medtronic BioPharma Sàrl
  • Merck Serono SA

Belgium

  • Dafra Pharma International
  • Delaval NV
  • European Association of Chemical Distributors (Fecc)
  • GIS EUROPE S.E.
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Johnson & Johnson
  • MSD
  • Nutriad International BV
  • Pfizer

France

  • Aptar Pharma
  • BD Medical – Pharmaceutical Systems
  • Galderma R&D
  • GALDERMA Recherche & Developpement
  • Naturex SA
  • Orphan Europe
  • Sanofi Pasteur SA

Germany

  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Pharma
  • Certara Germany GmbH
  • Evonik Industries AG
  • Takeda GmbH
  • Trilogy Writing & Consulting GmbH

Ireland

  • Allergan
  • Allergan Ltd
  • ENTERPRISE IRELAND
  • Pfizer Limited
  • RTE
  • Shire Pharmaceuticals

Denmark

  • Ferring Pharmaceuticals A/S
  • Novo Nordisk A/S
  • Xellia Pharmaceuticals ApS
  • Xellia Pharmaceuticals AsP

Italy

  • Abbvie Srl
  • Angelini Pharma s.p.a.
  • Chiesi Farmaceutici SPA

Croatia

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Pliva Croatia Ltd

Hungary

  • BRISTOL-MYERS SQUIBB KFT
  • Celgene Kft

Netherlands

  • Mallinckrodt Medical BV
  • Mallinckrodt Medical BV.

Norway

  • Targovax ASA
  • Weifa AS

Sweden

  • Fresenius Kabi AB
  • Swedish Orphan Biovitrum AB (publ)

Czech Republic

  • Arriello s.r.o.

Indonesia

  • BIOFARMA

Poland

  • Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Warsaw

Slovak Republic

  • Ewopharma International, s.r.o.

United Arab Emirates

  • Hoffman La Roche

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy