Presented by
Management Forum

EU Pharmaceutical Regulations & Strategy

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations. The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

11-12 Apr 2022 + 2 more dates

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

Course Overview

Creating and coordinating an effective regulatory strategy is an essential part of the work of a regulatory affairs department and can save valuable time and money.

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well as discussing the format for presentation of data, the registration procedure and post-authorisation strategic considerations and obligations. The impact of post-Brexit changes on obtaining and maintaining marketing authorisations in the UK will be considered.

There will be a number of case study sessions throughout the two days to explore options and strategies for these key regulatory activities, which will provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.

Benefits of attending

  • Understand the legal basis of the EU regulatory environment
  • Discuss development strategy and pre-submission activities
  • Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
  • Discuss post-authorisation strategic considerations and obligations
  • Explore the impact of post-Brexit changes

Who should attend?

The programme will be of value to regulatory affairs personnel and also to those who interact with regulatory personnel in order to understand action timelines and information requirements. It will be particularly relevant to all those working in:

  • Regulatory affairs
  • Project management
  • Business planning
  • Commercial management
  • Manufacturing and QA
  • Labelling and artwork
  • Medical information
  • Clinical
  • Pharmacovigilance

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The EU Pharmaceutical Regulations & Strategy course will cover:

EU regulatory environment: legal basis

  • Key regulations, directives and guidelines and information sources
  • Impact of the end of the Brexit transition period

Information sources

Case study one

Development and Strategy

  • Drug discovery
  • Scientific advice

Development process

  • Pharmaceutical R&D
  • Non-clinical tests
  • Clinical studies - Phase I to III

EU clinical trials Directive and new Clinical Trials Regulation

Types and categories of marketing Authorisations

The Common Technical Document (CTD)

  • Overview of Structure and content of a CTD

The European Medicines Agency (EMA)

  • Impact of the end of the Brexit transition period

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

Registration procedures

  • Coordination group
  • Decentralised procedure
  • Mutual recognition procedure
  • National procedures

Managing product labelling

Case study two

Abridged applications and Generic

  • Types and Requirements

Product Life Cycle; Post approval

Patents and SPCs

Parallel trade

  • How the process works
  • Impact of the end of the Brexit transition period

Post-authorisation obligations; pharmacovigilance, variations and renewals

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

Case study three

Renewals

Sunset clause

Phase IV Trials

Classification change

Generic development

Strategic factors

Successful products

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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 EU Pharmaceutical Regulations & Strategy Live online/Classroom training

11-12 Apr 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 11598

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 07 Mar

In your basket 

5-6 Jul 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11414

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 31 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 

18-19 Oct 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 11737

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 13 Sep

In your basket 

Reviews of IPI's EU Pharmaceutical Regulations & Strategy training course


The webinar was really ideal for persons/companies willing to register their product in the EEA. The speaker was also excellent, involving the attendants with her particular questions, which provided a broader content.

Oct 22 2020

Gokce Erdem
Regulatory Affairs Manager, Turgut Pharmaceuticals

Oct 22 2020

Very good knowledge of the topics from the speaker.

Inês Almeida
Regulatory Affairs Manager, BIAL - Portela & C.ª, S.A.

Oct 31 2019

Very good and comprehensive overview of the EU regulations with an emphasis on MAA. I particularly liked the case studies where we implemented what we had learnt – a very good way of checking if the material is understood.

Natalie De Jonge
Regulatory affairs Manager, Argenx

Apr 23 2018

Norah was clear, open for questions and sympathetic.

Vanina Premus Pogacar
Associate for Validation of Applications, Agency for Medicinal Products and Medical Devices

Apr 23 2018

I got what I expected. An overview of pharmaceutical legislation, speaker was great with huge knowledge.

Danijela Jurisic
Associate for Validation of Applications, Agency for Medicinal Products and Medical Devices

Apr 23 2018

Overall I found this useful – a good general overview.

Joanna Fitch
Regulatory Affairs Senior Manager, GSK Consumer Healthcare

Apr 23 2018

Solid content, the form was good, good speaker.

Marion Drouet
International Product Partner, Roche

Oct 30 2018

Good knowledge of the regulations and good speaker.

Matteo Lapini
Regulatory Affairs Therapeutic Area Lead, Menarini Ricerche s.p.a

Oct 30 2017

Very useful course to improve the understanding of European Requirements and the different types of procedures

Tonia Mazzarella
Regulatory Affairs, Zambon SpA

Oct 30 2017

Course content is very comprehensive and the presentation slides were also very thorough and appropriately referenced. Good speaker.

Suna Horner
Associate Medical Manager, HRA Pharma UK & IE Ltd.

Oct 30 2017

The course was informative, comprehensive and interactive. The venue was fantastic and Management Forum was well organised. The entire course was well put together. Brilliant experience!

Evelyn Olasegha
Senior Manager Regulatory Affairs, Mundipharma Research Ltd

Apr 6 2017

Very useful. The speaker was warm and very knowledgeable and I particularly liked the interactive style.

Carola Lempke
Senior Patent Attorney, AstraZeneca

Oct 6 2016

Speaker was personable, knowledgeable good place and tone.

Sorwar Choudhury
Head of Medical, Pharmacovigilance and Regulatory Affairs, Meda Pharmaceuticals Limited

Oct 6 2016

Interesting and very valuable course.

Sofie Stalmans
Regulatory Affairs, PhaRA BVBA

Oct 6 2016

Nice speaker - open for discussion.

Chantal Mutsaers
Regulatory Affairs Scientist, Phara Plus Life Science Services

Oct 6 2016

This kind of overall training covers a lot of topics, that's why it is very interesting.

Sophie Ferruit
Scientific writer, Monachem

Oct 6 2016

Overview good.

Gregor Schaefer
Medical Therapeutic Area Specialist, Galderma International

UK

  • Alan Boyd Consultants Ltd
  • Boots Management Services Ltd
  • Celgene
  • Clinigen Group PLC
  • Convergence Pharmaceuticals
  • GSK Consumer Healthcare
  • HRA Pharma
  • HRA Pharma UK & IE Ltd.
  • Marie Stopes International
  • Martindale
  • Meda Pharmaceuticals Limited
  • Medreich PLC
  • Mundipharma Research Ltd
  • Pfizer Ltd
  • Recipharm HC Limited
  • Shire Pharmaceuticals Development Ltd

Switzerland

  • Acino Pharma AG
  • Covis Pharma
  • F. Hoffmann-La Roche AG
  • F. Hoffmann-La Roche Ltd
  • Galderma S.A.
  • Galderma SA
  • Merck
  • Nestec SA
  • Roche
  • Shire International GmbH

France

  • BlueReg
  • Boehringer Ingelheim
  • Galderma International
  • Guerbet
  • Horus Pharma
  • Ipsen Pharma
  • Septodont
  • Voisin Consulting

Italy

  • Alfasigma SpA
  • Chiesi Farmaceutici S.p.a.
  • Menarini Ricerche s.p.a
  • Seqirus S.r.l
  • Sifi S.p.A.
  • Zambon SpA

Belgium

  • Argenx
  • Galapagos NV
  • PhaRA BVBA
  • Phara Plus Life Science Services
  • PhaRa PLUS Life Science Services (BVBA)

Netherlands

  • Mallinckrodt Medical B.V.
  • Mylan B.V.
  • Norgine BV

Croatia

  • Agency for Medicinal Products and Medical Devices
  • BELUPO Pharmaceuticals & Cosmetics Inc

Denmark

  • H. Lundbeck A/S
  • Novo Nordisk A/S

Germany

  • Bayer Pharma AG
  • medac GmbH

Ireland

  • Aspen
  • Teva

Sweden

  • AstraZeneca
  • Johnson & Johnson

Austria

  • AOP Orphan Pharmaceuticals GmbH

Czech Republic

  • Zentiva Group a.s.

Hungary

  • Mylan Hungary Kft

Monaco

  • Monachem

Portugal

  • BIAL - Portela & C.ª, S.A.

Saudi Arabia

  • Saudi Food and Drug Authority

Slovak Republic

  • Ewopharma International, s.r.o.

Turkey

  • Turgut Pharmaceuticals

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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