Medicademy - Medicademy Module R14: Veterinary Regulatory Affairs in the EU

Medicademy Module R14: Veterinary Regulatory Affairs in the EU

Registration deadline:
25 September 2013

Exam:
Date of examination: November 25, 2013

You can take the examination in your own country!

Medicademy arranges examinations at Embassies, Universities etc. all over the world.

Information about examination form etc. will follow.

Remember to register for the exam separately!

	Register Medicademy Module R14: Veterinary Regulatory Affairs in the EU
Price: DKK 17,000.00 VAT, 25% DKK 4,250.00 Incl. VAT DKK 21,250.00

Startdate:
23 October 2013 - 25 October 2013

Purpose:
The module aims to provide students with a comprehensive overview of the veterinary regulatory affairs environment in Europe.
It is targeted at regulatory employees from the veterinary and human industries as well as employees in the pharmaceutical industry, who may find it relevant. Any employee with a special interest in the veterinary regulatory environment in Europe will gain a better understanding of the pharmaceutical law frame, and the requirements and challenges within this particular field.

By the end of this module, the student should be able to:
- understand the basic principles of regulatory requirements for veterinary medicinal products in EU, including the pre-approval, approval, and post-approval phase.
- advise and decide on the optimal regulatory strategies for veterinary products
- analyse and evaluate veterinary regulatory requirements using relevant regulations and guidelines.

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Content:
• The Veterinary Scene
• The European System
• Safety and Residues Issues, including MRL – Maximum Residue Limits
• Clinical Trials
• Scientific Advice from CVMP and National Competent Authorities
• Marketing Authorisation Applications – Overview, Terminology and Organisation
• Procedures
• Content of Marketing Authorisation Applications, Part 1 - 4
• VNeeS – Authority View and Practical Aspects from the Industry
• Product Information (QRD-template, Product Information, Translational Issues)
• Life Cycle Management
• Pharmacovigilance
• Special Issues (Cascade Rule, MPMM – Minor Product Minor Market, Sunset Clause)
• Future and Trends (1-1-1 concept)

Course Leaders:

Karin Bay Andersen
Regulatory Affairs Manager, Dechra Veterinary Products A/S, Denmark

Erik de Ridder
Regulatory Affairs Director, Regulatory Affairs Strategy and Policy, Elanco, Belgium

Lecturers in 2011 - we expect to be able to employ the same lecturers in 2013:

Jill Kieffer
Head of Development and Evaluation of Veterinary Medicines, European Medicines Agency (EMA), UK

Erik de Ridder
Regulatory Affairs Director, Regulatory Affairs Strategy and Policy, Elanco, Belgium

Dr. Gabriel Beechinor
Director of Veterinary Medicines, Irish Medicines Board, Ireland

Anja Holm
CVMP Chair, Danish Medicines Agency, Denmark

Chris van de Eede
Associate Research Fellow, Veterinary Medicine Regulatory Affairs, Pfizer Animal Health, Belgium

Emma Duffy
Regulatory Affairs Manager, Novartis, Switzerland

Gareth Harris
Head of Global RA/PV/QA, Boehringer Ingelheim Animal Health GmbH, Germany

Sylvie Meillerais
Technical Project Manager, IFAH-Europe, Belgium

Corinne Philipe Reversat
Senior Manager Biologicals New Projects EU, Merial, France

Per Helboe
MSc, PhD, DSc, former Senior Director, Licensing Division, Danish Medicines Agency, Denmark

Ray Harding
Consultant, Cyton Biosciences Ltd, UK

Target:
It is targeted at regulatory employees from the veterinary and human industries as well as employees in the pharmaceutical industry, who may find it relevant. Any employee with a special interest in the veterinary regulatory environment in Europe will gain a better understanding of the pharmaceutical law frame, and the requirements and challenges within this particular field.

Prerequisites:
In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt.

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.

Literature:
A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module.

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.

Mail us for more information

Plads til diskussion – rigtig godt

Ann-Lisbeth Aarup Nielsen - ALK-Albelló - Regulatory Affairs Officer

Tina Jensen

Tina Jensen is Program Director, Medicademy Regulatory Affairs and responsible for Introduction to Drug Registration.

tj@medicademy.net

Phone: +45 39 15 09 14

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