WORKING THROUGH
VETERINARY DRUG
DEVELOPMENT IN THE
EU AND USA - 5 Day
Residential Course -
London

Conference Date: 15-19 Jun 2009
Conference Ref: V6-8109
Fee: £2950 + VAT
Venue: The Rembrandt Hotel, London

25% Discount for members of the Animal Health Institute, USA

A Practical Five Day Course with Interactive Workshops which will cover:

• EU Regulatory Framework
• Assessing Development Candidates
• Project Team: R & D and Marketing
• Pre-formulation Development
• Pharmaceutical Development
• Process Scale-Up and Validation
• Expert Report on ‘Quality’
• Understanding How to ‘Block Out Studies’
• Developing the Toxicological Package
• EU User Safety Risk Assessment
• Maximum Residue Limits Dossier - Safety
• FDA Approach to Safety Studies
• USA Regulatory Framework
• USA Regulatory Strategies and Procedures
• Pharmacokinetics and Bioequivalence
• Metabolism and Residues
• MRLs Dossier: Residues and Withdrawal Periods
• FDA Evaluation of Consumer Safety
• Planning Pre-Clinical and Clinical Development
• Environmental Risk Assessment
• EU and US Clinical Development
• EU and US Target Animal Safety
• EU Clinical Expert Report
• EU Regulatory Strategies and Procedures
• Managing the USA Regulatory Submission
• Writing the EU Regulatory Submission

Chaired by Ray Harding - Managing Director, Cyton Biosciences Ltd., UK

Tutors:
Dr Katie Barrett - Programme Director for Agrochemical & Veterinary Programmes, Huntingdon Life Sciences, UK
Julian Braidwood - Managing Director, Triveritas, UK
Dr Raymond P Munden - Pharmaceutical Consultant, UK
Dr David Petrick - President & Founder, Delta Consortium Regulatory Consulting Ltd. USA

Click here to register for this unmissable event.

Members of AHI, USA will receive a 25% discount off the registration fee. Please quote AHI09 when registering to receive the offered discount.  

For further information on the AHI, please click here