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Management Forum

EU (European Union) Pharmaceutical Regulations & Strategy Training Course

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.

★★★★★ "Excellent presenter! Truly professional!"

11-12 June 2024
+ 14-15 October 2024 »

from £1099

Need help?  Enrol or reserve

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 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 an overview of the format for presentation of data, the registration procedures for obtaining marketing authorisations and post-authorisation obligations and strategic considerations. The impact of post-Brexit changes for 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.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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
  • Discuss the proposed EU pharmaceutical legislation changes

 

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 and would benefit from 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
  • Proposed EU pharmaceuticals legislation (specific changes will be discussed in the relevant section of the programme)

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

Adaptive marketing authorisation procedures

The Common Technical Document (CTD)

  • Overview of Structure and content of a CTD

Procedures for obtaining a marketing authorisation in the EU with discussion on the impact of Brexit and the proposed EU legislation changes

  • The EMA
  • The EU centralised procedure

Other EU centralised procedures

  • Referral and arbitration

 

Other procedures for obtaining a marketing authorisation in the EU

  • 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 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

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

11-12 June 2024

Classroom
Rembrandt Hotel
London

09:30-17:00 UK (London)
Course code 13715
Optional £270/€351/$405 per night

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

Until 07 May

  • 2 days classroom-based training
  • Optional accommodation - 2 nights including breakfast, checking in the day before the course
  • 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

14-15 October 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 13943

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

Until 09 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


Excellent presenter! Truly professional!

Oct 16 2023

Anastasios Stylianos Karountzos
Regulatory Affairs Officer, Pharmathen

Oct 16 2023

Good overview of the Pharmaceutical Legislation and interesting summary of future changes in the legislation framework. Case studies were a good opportunity to discuss regulatory strategies.

Adriana Lopes
Regulatory Affairs, Bluepharma Indústria

Oct 18 2022

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

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. It helped to connect lots of the regulatory knowledge i had

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
  • Galapagos
  • 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
  • zaitun ltd

Switzerland

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

Italy

  • Alfasigma
  • Alfasigma SpA
  • Chiesi Farmaceutical SpA
  • Chiesi Farmaceutici S.p.A.
  • Chiesi Srl
  • Menarini Ricerche s.p.a
  • MENARINI RICERCHE SPA
  • Seqirus S.r.l
  • Sifi S.p.A.
  • Zambon SpA

France

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

Belgium

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

Germany

  • Bavarian Nordic GmbH
  • Bayer Pharma AG
  • HEXAL
  • medac GmbH

Denmark

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

Netherlands

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

Portugal

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

Spain

  • Dentaid SL
  • Italfarmaco S.p.A.
  • Lilly S.A.

Sweden

  • AstraZeneca
  • Johnson & Johnson
  • Johnson and Johnson

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

Ireland

  • Aspen
  • Teva

Poland

  • Haleon
  • Haleon Poland Sp. z o.o.

Slovak Republic

  • Ewopharma International s.r.o
  • Ewopharma International, s.r.o.

Brazil

  • Sanofi

Czech Republic

  • Zentiva Group a.s.

Greece

  • Pharmathen

Hungary

  • Mylan Hungary Kft

Korea, Republic Of

  • AJOU University

Latvia

  • AS Kalceks

Monaco

  • Monachem

Saudi Arabia

  • Saudi Food and Drug Authority

Turkey

  • Turgut Pharmaceuticals

United States of America

  • Ultragenyx Pharmaceutical Inc.

Enrol or reserve

Run EU Pharmaceutical Regulations & Strategy Classroom/Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • 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:

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

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy