Presented by
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"
26-29 September 2023
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
Working in pharmaceutical regulatory affairs is a challenging 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 also covers pharmacovigilance and safety reporting with sessions on licence variations and the commercial aspects of pharmaceutical products. 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
- Discussion of the impact of Brexit
- Contribute to your Continuing Professional Development (CPD)
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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 regulatory procedures and activities.
The Regulatory Affairs for Support Staff course will cover:
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
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.
Book Regulatory Affairs for Support Staff Live online training
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
26-29 September 2023
Live online
13:30-16:30 UK (London) (UTC+01)
14:30-17:30 Paris (UTC+02)
08:30-11:30 New York (UTC-04)
Course code 12341
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 22 Aug
- 4 sessions of 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
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.
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 
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 
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
United Kingdom
- Abbvie Ltd.
- Achenyo Ochuma
- ADVANZ PHARMA
- Air Products plc
- Alcon
- Allergan UK Limited
- Almirall Ltd
- Almus
- Almus Pharmaceuticals Ltd
- Amgen Ltd
- AndersonBrecon (UK) Limited
- 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
- NDA Regulatory Science Ltd, Grove House
- Norgine Limited
- Norgine LTD
- Novella Clinical, a Quintiles Company
- Parapharm Development LTD
- PAREXEL Consulting
- Patheon UK Ltd
- PCI Pharma Services
- Prostrakan
- Reckitt Benckiser Healthcare (UK) Ltd
- RWS Group
- Sanofi
- 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
Germany
- Boehringer Ingelheim Animal Health GmbH
- Boehringer Ingelheim Pharma
- Certara Germany GmbH
- Evonik Industries AG
- Takeda GmbH
- Trilogy Writing & Consulting
- Trilogy Writing & Consulting GmbH
- Trilogy Writing GmbH
France
- Aptar Pharma
- BD Medical – Pharmaceutical Systems
- Galderma R&D
- GALDERMA Recherche & Developpement
- Naturex SA
- Orphan Europe
- Sanofi Pasteur SA
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
Sweden
- Camurus AB
- Fresenius Kabi AB
- Swedish Orphan Biovitrum AB (publ)
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
Czech Republic
- Arriello s.r.o.
Indonesia
- BIOFARMA
Poland
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Warsaw
Saudi Arabia
- Gulf Health Council
Slovak Republic
- Ewopharma International, s.r.o.
United Arab Emirates
- Hoffman La Roche
Run Regulatory Affairs for Support Staff Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
