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Management Forum

Variations to Marketing Authorisations Training Course

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

★★★★★ "The webinar content corresponded to what I was expecting ; I thought it was very good that Andrew as... more (9)"

4-5 June 2024
+ 28-29 November 2024 »

from £1099

Need help?  Enrol or reserve

Course overview

It is a key post-marketing responsibility of the marketing authorisation holder (MAH) to keep dossiers up to date, and changes must be submitted as variations to the appropriate regulatory authority.

This interactive event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. The course will cover the latest variation regulations and offer guidance from an industry expert on how to optimise your regulatory procedures to help achieve faster approval. The programme will include filing tips and strategies with information and advice on creating a global dossier and implementation periods.

Practical sessions throughout the two days will provide an opportunity to discuss different scenarios and strategies with other participants.

Benefits of attending:

  • Gain an overview of the EU system for variations
  • Assess how pharma companies are working in this evolving regulatory environment
  • Profit from practical advice on the preparation and submission of variation applications
  • Understand the impact of Module 3 on your variations dossier
  • Discuss filing tips and strategies to help achieve faster approval

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

Who should attend?

This course will be particularly relevant for those working in registration and regulatory affairs. It will also be of interest to anyone with an involvement in the variations process including QA, clinical safety and pharmacovigilance personnel.

Enrol or reserve

The Variations to Marketing Authorisations course will cover:

Basis of EU Regulations 1234/2008 and 712/2012

  • Classification in accordance with the legislation
  • Understand the differences between type lA, type IB and type ll variations
  • Clarify foreseen and unforeseen variations

Special topics in variations

  • Handling active ingredient master files as variations
  • Submission of new clinical data

Practical session: Analysing and classifying the different changes

Grouping and work-sharing

  • Understanding when grouping is appropriate
  • Clarifying what types of variations may be grouped
  • Guidance on assembling a grouped submission
  • Understanding when work-sharing is appropriate

Understanding Module 3

  • The dossier impact on variations
  • QbD
  • CQA pyramids

Practical session: Understanding reviewers

Filing strategy

  • Creating a global dossier (gold/silver/ bronze versions)
  • Understanding implementation and grace periods
  • Fixed and rolling implementation strategy

Practical session: Plan the timelines/project management of a variation submission

Other procedures

  • Article 5
  • Urgent safety restrictions
  • Understanding when to use extension applications

Submission planning

  • Identify and understand strategic considerations

Data requirements for type II variations

  • Learn how to identify and support a type II change

Practical session: Data requirements for more complex changes

Variations through national procedures and differences from centralised procedure

  • Understand the procedures
  • Languages and translations
  • Explore the linguistic review process

Mutual recognition and decentralised procedures for variations

  • Understand the procedures and responsibilities of the MAH, RMS and CMS
  • Learn how to efficiently plan for and run an MR variation procedure

Practical session: A variation to an example MRP authorised product including planning timelines and impact of referrals

Advanced compliance

  • Creating your own compliance requirements
  • SUPAC guidance

Enrol or reserve

Andrew Willis
San Salvatore Training Ltd

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

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

4-5 June 2024

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 13753

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

Until 30 Apr

View basket 

 
Not ready to book yet?

for 7 days, no obligation

28-29 November 2024

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 13936

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

Until 24 Oct

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 Variations to Marketing Authorisations training course


The webinar content corresponded to what I was expecting ; I thought it was very good that Andrew asked the participants lots of questions as it made the webinar more enjoyable and engaging.

Feb 1 2024

Liz Hui
Regulatory Affairs Executive, Dermal Laboratories Ltd

Oct 12 2023

The presentation was great and the speakers have excellent knowledge on their field. I hope to join another webinar soon.

Mairi Zadik
CMC Regulatory Compliance Officer, Pharmathen

Jun 6 2023

What I liked most about Andrew was the inspiring way of explaining the various sections of the webinar, making it interactive with everyday life examples, questions and practical exercises

Filippo Mandolfino
GLOBAL RA SPECIALIST, Angelini Pharma s.p.a.

Oct 12 2023

Really good. The speakers did a wonderful job explaining everything.

Daphne Sotiriou
Regulatory Affairs Officer, Wockhardt UK Ltd

Oct 13 2022

Excellent presentations and course material. Always better face to face, but digital plateform worked well. All very clear. Alot was covered during two days. The case studies made me practise what we were taught.

Louisa Dew
Regulatory Affairs Consultant, NDA Regulatory Science Ltd

Apr 13 2021

Excellent webinar! [Speaker is] engaging and friendly.

Abhijit Nair
Regulatory Affairs Officer, Consilient health

Apr 13 2021

It was very interesting and informative.

Dubravka Božičević
Senior Advisor for Validation of Applications, Cratian Agency for medicinal products and medical devices - HALMED

Oct 8 2020

Excellent, clear and interactive

Mohit Pandey
Morningside Healthcare Limited

Oct 8 2020

Andrew is a good speaker and managed to keep our attention during these two days despite the fact that it was a webinar.

Chloë Braud
International Regulatory Affairs Pharmacist, Guerbet

United Kingdom

  • 3M Healthcare Ltd
  • Abbott Laboratories Ltd
  • Allergan UK Limited
  • Allergy Therapeutics Ltd
  • Alliance Pharmaceuticals Ltd
  • Almac Group
  • Archimedes Pharma Ltd
  • Archimedes Pharma UK Limited
  • Avon Automotive plc
  • Bayer Healthcare
  • BlueReg Pharma Consulting
  • BOC Ltd (part of the Linde Group)
  • Boehringer Ingelheim Ltd
  • Bristows LLP
  • Britannia Pharmaceuticals Ltd
  • Chemidex Pharma Ltd
  • Chiesi Limited
  • Co-Operative Pharmacy
  • Consilient health
  • Cross Vetpharm Group UK LTD
  • Cyton Biosciences Ltd
  • Dechra Ltd
  • Dermal Laboratories
  • Dermal Laboratories Ltd
  • E.C. De Witt & Company Limited
  • Eli Lilly & Co Ltd
  • Ethypharm
  • Fresenius Kabi Ltd
  • Fresenius Kabi UK Ltd
  • Galderma (UK) Limited
  • Galen Ltd
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • Ipsen Biopharm Ltd
  • Janssen-Cilag Ltd
  • JensonR+ Ltd
  • Karib Kemi Pharm Ltd
  • Lundbeck Limited
  • Martindale
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mentholatum Co Ltd
  • Milpharm Ltd/Aurobindo Pharma Limited
  • Morningside Healthcare Limited
  • Mylan
  • NAPP PHARMACEUTICALS
  • NDA Regulatory Science Ltd
  • Novartis Pharmaceuticals UK Ltd
  • Pierre Fabre Ltd
  • Procter & Gamble Technical Centres Ltd
  • Ranbaxy Laboratories Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Limited
  • S A Consultancy Ltd
  • Sanofi Pasteur MSD Ltd
  • Shire Pharmaceutical Ltd
  • SHORE LTD
  • SincasPharma Limited
  • Sinclair IS Pharmaceuticals Ltd
  • Terumo BCT
  • Teva Pharmaceuticals Europe B.V.
  • Teva UK Ltd
  • Torbay Pharmaceuticals
  • UCB Celltech
  • Waymade Plc
  • Winthrop Pharmaceuticals UK Ltd
  • Wockhardt UK Ltd
  • Wrafton Laboratories Ltd, t/a Perrigo

Belgium

  • GRUNENTHAL NV
  • Janssen Pharmaceutica NV
  • Nikkiso Belgium
  • PHARA Plus Life Science Services BVBA
  • SCHERING-PLOUGH LABO NV

Switzerland

  • Medtronic BioPharma Sàrl
  • Novartis International AG
  • Novartis Vaccines & Diagnostics AG
  • ObsEva
  • Tillotts Pharma AG

France

  • Galderma International
  • Guerbet
  • HRA Pharma Rare Diseases
  • Sanofi Pasteur MSD

Ireland

  • Chanelle Medical Unlimited Company
  • Irish Patents Office
  • Jazz Pharmaceuticals
  • Labopharm Europe Ltd

Netherlands

  • Abbott Healthcare Products BV
  • Intervet Nederland bv
  • Leyden Delta bv
  • Viatris

Denmark

  • Atnahs Pharma Nordics
  • Ferrosan Medical Devices A/S
  • Novo Nordisk A/S

Italy

  • Angelini Pharma s.p.a.
  • Chiesi Farmaceutici S.p.A.
  • SIFI S.p.A.

Croatia

  • Cratian Agency for medicinal products and medical devices - HALMED
  • Novartis Hrvatska doo

Czech Republic

  • Zentiva Group AS
  • Zentiva ks

Israel

  • Blau Pharmaceutical Services
  • Perrigo Israel Pharmaceuticals Ltd

Latvia

  • AS KALCEKS
  • JSC Olainfarm

Portugal

  • Bluepharma - Indústria Farmacêutica, SA - VAT PT505282801
  • Fresenius Kabi Pharma Portugal, Lda

Spain

  • Casen Recordati SL
  • Grifols,S.A.

Sweden

  • Camurus AB
  • Fresenius Kabi AB

Australia

  • Phebra Pty Limited

Austria

  • EVER Valinject GmbH

Germany

  • Life Molecular Imaging

Greece

  • Pharmathen

Malta

  • Eugia Pharma (Malta) Ltd

Mauritius

  • Aspen Global Incorporated

Poland

  • Aspen Pharma Ireland Limited Spółka z Ograniczoną Odpowiedzialnością Oddział w Polsce

Romania

  • Antibiotice SA

Slovak Republic

  • Ewopharma International s.r.o

Enrol or reserve

Run Variations to Marketing Authorisations 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