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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"

27-28 Jun 2022 + 1 more date

Need help?  Enrol now

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

Course overview

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

This interactive course is designed for those working in a support staff 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 Great Britain and Northern Ireland will be discussed.

The programme will cover 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
  • Discussion of the impact of Brexit
  • 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

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 will also be of value to those who interface with the regulatory affairs function or 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 requirements?

  • The internet
  • Approvals and withdrawals

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

The EU centralised procedures

  • EU centralised procedure for marketing authorisation
  • Referral and arbitration

Non-centralised procedures for marketing authorisation in the EU with discussion on the impact of Brexit

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

Generic applications

  • Types and 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

Pharmacovigilance and GCP inspections including discussion on the impact of Brexit

  • Requirements and criteria

Licence variations

  • Types 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 Classroom/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*

27-28 Jun 2022

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 11931

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

Until 23 May

Limited places remaining

  • 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

View basket 

27-28 Sep 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 11703

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

Until 23 Aug

View basket 

* 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 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

United Kingdom

  • Abbvie Ltd.
  • Achenyo Ochuma
  • ADVANZ PHARMA
  • 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
  • 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
  • Trilogy Writing 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

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

Slovak Republic

  • Ewopharma International, s.r.o.

United Arab Emirates

  • Hoffman La Roche

Enrol now

Run Regulatory Affairs for Support Staff Classroom/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 expert Aleksandra Beer 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:

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