This module is targeted at regulatory employees, who wish to improve their understanding of regulations and legal frameworks with an impact on Product Life Cycle Management, and of how to apply this understanding in regulatory Product Life Cycle Strategies. Students will gain knowledge and insight into regulatory requirements and opportunities in Life Cycle Management.

By the end of this module, the student should be able to:

• Understand the basic principles of regulatory requirements for a pharmaceutical product in the post-approval phase, including how and when to apply for variations for CMC changes, labelling updates, SmPC updates, and renewals, as well as the regulations on paediatrics, risk management plans, referrals and generics

• Analyse and evaluate regulatory concerns and risks in life cycle management using relevant regulations and guidelines

• Advise and decide on the optimal regulatory strategies for life cycle management projects

• Use best practises in order to maintain regulatory compliance

In short, this module will provide students with a good base of knowledge of regulatory advice on the possibilities and consequences of different types of life cycle activities, and enable them to develop strategies, plan and perform activities related to the regulatory maintenance of a product in an everyday working environment.

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The programme will concentrate on EU Product Life Cycle Activities, and will provide an update on the latest regulatory requirements, e.g. the new EU variation legislation and guidelines and paediatric regulation, however also give a brief insight on differences across regions, e.g. EU, US, BRIC and Japan.

• The EU Variation System
• Experiences from “real-life” – Authority and Industry Angle
• Change Control Systems and how to be Regulatory Compliant
• Pharmacovigilance
• Safety Changes to the SmPC
• New Indications and Extensions
• Paediatric Regulation
• The Patient Leaflet and Labelling Requirements
• Renewals
• Crisis Management
• Risk Management Plans
• Referrals
• Intellectual Properties and Generic Competition – Originator Company point of view
• Regulatory strategies – Generic Company point of view
• Regulatory differences to consider in Life Cycle Management – Important Markets outside EU

During the 3 days you will meet very experienced speakers with significant competencies in the different regulatory disciplines both from Competent Authorities and Pharmaceutical Industry. Learning will be enhanced through interaction with the other participants, while working in groups on a case story, illustrating the considerations to be made for the different opportunities and issues arising during the life cycle of a product.


Course Leaders:

Bente Brunbakke,
RA Senior Project Manager, Insulin Finished Products, Novo Nordisk A/S, Denmark

Helle Langgaard,
Head Regulatory Affairs Products, LEO Pharma A/S, Denmark

Lecturers:

Sonia Ribero
European Medicines Agency Lead of Variation Section, UK

Dr. Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany

Dr. Harald Tietz
Director, Global Patient Safety & Regulatory Affairs, Lilly, Germany

Doris Irene Stenver
Chief Medical Doctor, Danish Medicines Agency, Denmark

Adrian Andrews
Regulatory Affairs Manager Hospitals, Teva Pharmaceuticals Europe, United Kingdom

Janne Malene Kampmann
Head of Section, Neurology Section, International Safety and Pharmacovigilance, H. Lundbeck, Denmark

Bettina Twile
Director International Regulatory Affairs, Product Life Cycle Management, Nycomed ApS, Denmark

Hanne Brokopp
Director, Regulatory Affairs Europe, Merck, Sharp & Dohme (Europe), Belgium

Pilar Carrero
Safety Medical Writing Group Team Leader at the Dept. of Safety Surveillance Diabetes, Novo Nordisk A/S, Denmark

Katja Gustafsson
Associate Director, Urology, Lifecycle Management, Global Regulatory Affairs, Ferring Pharmaceuticals A/S, Denmark

Sonja Horsted
Senior R&D Project Manager, LEO Pharma A/S, Denmark

Marianne Garibay
Senior Regulatory Project Manager, Regulatory Affairs, Marketed Products, Insulin Drug Product CMC, Novo Nordisk A/S, Denmark

Dorthe Strobel
Senior Regulatory Pro¬cess Manager Regulatory Affairs, Global Processes, Novo Nordisk A/S, Denmark

Wim Dartee
Global TA Lead and US Group Head, Regulatory Affairs, Novartis Pharma AG, Switzerland

Anders Schroll
Divisional Director, Corporate Communication, H. Lundbeck A/S, Denmark

Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area. These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module. The participation will be considered on a case-by-case basis.

The list will be divided into mandatory and optional reading. The mandatory references is part of the examination syllabus.

The participants are expected to study and be familiar with the mandatory references in advance of the module.

Accomodation:
Hotel Twentyseven
Hotel Twentyseven is located in the heart of Copenhagen, close to the Town Hall Square, the Tivoli Gardens, and Copenhagen Central Station, and airport trains, S-trains, regional trains, and busses leave from the sta­tion regularly. Hotel Twentyseven has a special atmosphere based on unique experiences, living design, seductive comfort, hospitality, and an uncomplicated life. All the 200 rooms in the hotel have been designed in the well-known Scandinavian design tradition by leading Danish designers & architects. www.hotel27.dk 
Fixed prices – breakfast included: Small single room - DKK 930 (approx. EUR 125), Double room for 1 person – DKK 1,080 (approx. EUR 145)

Transportation - Included in the Course Fee!
Medicademy arrange transportation every day from Hotel Twentyseven in the morning to Medicademy and back again in the evening from Medicademy to Hotel Twentyseven – included in the course fee!

Networking Dinner - Included in the Course Fee!
The networking dinner takes place at Hotel Twentyseven on the first night of the module - May 29, 2012!