Presented by
Management Forum
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)"
29-30 January 2024
+ 13-14 May 2024, 24-25 September 2024 »
from £1099
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 or interactive role and provides a valuable introduction to pharmaceutical regulatory affairs and key responsibilities.
Participants will gain an overview of current and proposed changes to EU legislation and regulatory procedures required to register products in the EU and the regulatory activities that must be complied with to maintain 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 renewals. The course will provide understanding of the role 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:
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
29-30 January 2024
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 13458
Until 25 Dec
Not ready to book yet?
for 7 days, no obligation
13-14 May 2024
Classroom
Rembrandt Hotel
London
09:00-17:00 UK (London)
Course code 13660
Optional £265/€380/$435 per night
Until 08 Apr
Not ready to book yet?
for 7 days, no obligation
24-25 September 2024
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 13891
Until 20 Aug
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.
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
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2 days
Typical duration
Pricing from:
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:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: