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Management Forum

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.

★★★★★ "Highly recommended course for anyone wishing to learn more about their involvement within the regula... more (27)"

22-23 September 2025 »
from £1299

Need help? Enrol/reserve

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

Course overview

Attend this interactive course to gain a valuable introduction to pharmaceutical regulatory affairs and key responsibilities, essential for those in support or interactive roles.

Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where an understanding of pharmaceutical regulatory affairs is important.

This interactive course is designed for professionals in support or interactive roles, offering a valuable introduction to pharmaceutical regulatory affairs and their key responsibilities.

Participants will gain an overview of current and proposed changes to EU legislation and regulatory procedures necessary to register products in the EU and the regulatory activities required to maintain products on the market. The UK is no longer a member of the EU but interactions and collaboration with the EU and other regulatory agencies for obtaining and maintaining marketing authorisations in the UK will be discussed.

This course aims to enhance understanding of the role of regulatory affairs, enabling support staff to perform more effectively and efficiently.

Interactive discussion sessions and practical case studies will help to consolidate learning, providing attendees with the skills and knowledge to be effective in their roles within the pharmaceutical industry.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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
Contribute to your Continuing Professional Development (CPD)

Who should attend?

This course is designed for personnel wishing to gain an understanding of regulatory affairs in the pharmaceutical industry, including:

Administrators
Assistants
Support staff

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

Enrol/reserve

This course will cover:

Day 1
Day 2

Current EU legislation

Background
Proposed changes to EU legislation

The internet
Other sources

Drug Development

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

Clinical trials in Europe

Seeking scientific advice in Europe

Marketing Authorisations

Types of and categories for marketing authorisations

Overview of the structure and content of a CTD

Procedures for Marketing Authorisation in the EU

EU centralised procedures

The EMA
The Centralised Procedure (CP)
Referral and arbitration

Non-centralised procedures for marketing authorisation in the EU and in the UK

Co-ordination group
Decentralised procedure (DCP)
Mutual recognition procedure (MRP)
National procedures
Procedures in the UK

Abridged applications and generics

Types and requirements

Product life cycle; post approval

Parallel trade

Post-authorisation obligations

Pharmacovigilance

Licence variations

Types and timelines

Extensions

Renewals

Sunset clause

Managing and supporting a regulatory affairs department

Enrol/reserve

Norah Lightowler
Lightowler Associates

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

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

22-23 September 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14941

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 18 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

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

I hope to gain a basic understanding of Reg affairs, I think for myself the course was perhaps aimed at a slightly higher knowledge base than I have to be able to fully appreciate the course.

Sep 27 2022

Isabelle Watkins United Kingdom
Compliance Lead, AndersonBrecon (UK) Limited

Sep 29 2020

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 Switzerland
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 Switzerland
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 United Kingdom
Regulatory Affairs Officer, Kyowa Kirin International

Sep 23 2019

Great speaker

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

Sep 23 2019

Great speaker.

Ena Mrakužić Croatia
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 Switzerland
Administrative Assistant, Debiopharm International SA

Sep 20 2018

[The speakers were] very knowledgable.

Therese Metzsch Denmark
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 Denmark
eCTD Specialist, Xellia Pharmaceuticals ApS

Feb 22 2018

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

Elliot Statham United Kingdom
Business Development Specialist, Creo Pharma Ltd.

Feb 22 2018

Very interesting content and well explained by speaker

Charlotte Sellwood United Kingdom
Regulatory Information Executive, Bayer PLC

Feb 22 2018

The course, presentation and speaker were all brilliant

Jamie Jardine United Kingdom
Administrative Officer, Veterinary Medicines Directorate

Feb 22 2018

Interesting and informative. Good speaker, very knowledgable.

Marissa Ashfield United Kingdom
Pharmacovigilance - AO, Veterinary Medicines Directorate

Sep 20 2018

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

Sarah Bourgin Switzerland
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 Netherlands
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 United Kingdom
RA Business Support Specialist, Abbvie Ltd.

Sep 28 2017

All very good

Karen Scott United Kingdom
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 United Kingdom
Regulatory Conformance Manager, Norgine Ltd

Oct 17 2016

Interesting and very enjoyable

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

Oct 17 2016

Very informative

Roshini Nellailingam United Kingdom
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 United Kingdom
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 United Kingdom
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 Germany
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 United Kingdom
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 United Kingdom
Regulatory Affairs Assistant, Glenmark Pharmaceuticals Europe Limited

Oct 17 2016

Very useful and enjoyable

Hannah Lee United Kingdom
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 United Kingdom
Director & Consultant, GalenAuxi Ltd

United Kingdom