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Management Forum

EU (European Union) Pharmaceutical Regulations & Strategy Training Course

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 webinar was really ideal for persons/companies willing to register their product in the EEA. The... more"

20-23 Feb 2023
+ 2 more dates

Need help?  Enrol or reserve

  • 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 impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical markets in Great Britain and Northern Ireland will be discussed.

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

Case studies and discussion sessions throughout the two days will explore options and strategies for key regulatory activities and will provide an opportunity to share experiences with our expert trainer and other delegates.

Benefits of attending

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

 

Who should attend?

The course is designed primarily for regulatory affairs personnel, however it will also be of value to those who interact with the regulatory affairs function in order to gain an understanding of 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

Enrol or reserve

The EU Pharmaceutical Regulations & Strategy course will cover:

EU regulatory environment: legal basis

  • Key regulations, directives and guidelines
  • Impact of Brexit

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 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)

  • Structure and function

Applying for a marketing authorisation in the EU with discussion on the impact of Brexit

  • The EU centralised procedure for marketing authorisation

Other EU centralised procedures

  • Referral and arbitration

Other registration procedures

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

Managing product labelling

Case study two

Abridged applications and Generics

  • Types and Requirements

Product Life Cycle; Post approval

Patents and SPCs

Parallel trade

  • How the process works
  • Impact of Brexit

 

Post-authorisation obligations; pharmacovigilance, variations and renewals

Pharmacovigilance and GCP inspections including discussion on the impact of Brexit

Licence variations

  • Type I and Type II variations and timelines
  • Procedures and timelines

Extensions

Case study three

Renewals

Sunset clause

Phase IV Trials

Classification change

Generic development

Strategic factors

Criteria for successful products

Enrol or 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

Book EU Pharmaceutical Regulations & Strategy Live online/Classroom 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

20-23 Feb 2023

Live online

13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 12111

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 16 Jan

View basket 

 
Not ready to book yet?

for 7 days, no obligation

13-14 Jun 2023

Classroom
Rembrandt Hotel
London

Course code 12252

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 09 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

16-17 Oct 2023

Live online

Course code 12382

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 11 Sep

View basket 

 
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 EU Pharmaceutical Regulations & Strategy training course


Overall it was a good webinar that covered a wide range of topics essential for professionals working in or close to regulatory affairs

Oct 18 2022

Sara D'Onofrio
Technical Unit Specialist, Alfasigma

Apr 11 2022

Very knowledgeable and patient with questions

Olayinka Oyeneyin
Manager Regulatory Affairs, Johnson & Johnson EAME

Apr 11 2022

Good overview of the regulatory topics concerning the product life-cycle. Availability to clarify and discuss doubts; challenge of the participants mind set;

Maria Inês Versos
Regulatory Affairs, Bluepharma - Indústria Farmacêutica, SA

Oct 18 2022

Content et presentation very clear

Mathilde Pleurmeau
Regulatory Affairs Officer, HRA Pharma Rare Diseases

Oct 21 2021

Excellent training session, highly recommended.

Magali Le Goff
Director Scientific Writing & Regulatory Sciences, BlueReg

Oct 22 2020

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.

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

United Kingdom

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

Switzerland

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

France

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

Italy

  • Alfasigma
  • Alfasigma SpA
  • Chiesi Farmaceutici S.p.a.
  • Menarini Ricerche s.p.a
  • MENARINI RICERCHE SPA
  • 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)

Germany

  • Bayer Pharma AG
  • HEXAL
  • medac GmbH

Netherlands

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

Austria

  • AOP Orphan Pharmaceuticals GmbH
  • Boehringer Ingelheim Regional Center Vienna GmbH & Co KG

Croatia

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

Denmark

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

Ireland

  • Aspen
  • Teva

Portugal

  • BIAL - Portela & C.ª, S.A.
  • Bluepharma - Indústria Farmacêutica, SA

Spain

  • Dentaid SL
  • Lilly S.A.

Sweden

  • AstraZeneca
  • Johnson & Johnson

Czech Republic

  • Zentiva Group a.s.

Hungary

  • Mylan Hungary Kft

Korea, Republic Of

  • AJOU University

Monaco

  • Monachem

Saudi Arabia

  • Saudi Food and Drug Authority

Slovak Republic

  • Ewopharma International, s.r.o.

Turkey

  • Turgut Pharmaceuticals

Enrol or reserve

Run EU Pharmaceutical Regulations & Strategy Live online/Classroom 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