This *In-house* course will provide a comprehensive introduction to the entire development programme for companion animal medicines.
This In-house course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological, pharmacological, safety risk assessments, clinical development, and regulatory submissions. An important part of the course will be devoted to working on case studies in the workshop sessions.
Your next step is to call us now on +44 (0)20 7749 4730 or email us at firstname.lastname@example.org or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.
Introduction and Objectives of the Course
EU Regulatory Framework
Assessing Development Candidates
Introduction to Workshop
Process Scale up and Validation
Workshop: Understanding How to “Block Out Studies”
The Toxicological Package
User Safety: Risk Assessment
Pharmacokinetics and Bioequivalence
Environmental Risk Assessment
Planning Pre-Clinical and Clinical Development
EU Regulatory Strategies and Procedures
Target Species Tolerance
Minor Use and Minor Species (MUMS)
Final Workshop Session
Writing and Managing the Regulatory Submission
Dr. Julian Braidwood
Dr. Julian Braidwood qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. He has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA. Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.
Julian Braidwood qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. Julian has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he co-founded Triveritas in 2,000 which grew rapidly internationally and became part of knoell in 2021. knoell is one of the leading service providers for worldwide registration and regulatory compliance in crop protection, crop nutrition, chemicals, cosmetics, animal health products, and medical devices. The knoell Group employs almost 600 people worldwide in more than 14 countries.
knoell is the only knowledge-based animal health consultancy and clinical studies specialist with its own technical staff based on three continents: North America, Europe, and Asia. The animal health team offers a full portfolio of services, including start-to-finish product development and ad hoc services – in all domesticated species for pharmaceuticals and biologicals, feed additives, novel, generic and borderline products.
Dr Raymond Munden has over 40 years’ experience in pharmaceutical research and development and was formerly Head, Analytical Services Europe for GlaxoSmithKline. He has led project teams that developed many new chemical entities and their pharmaceutical products that were successfully taken to market. Dr Munden has particular expertise in stability protocol design and testing, stability storage facilities, experimental design and degradation chemistry. He is now a consultant for all aspects of pharmaceutical development.
We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
See below or contact us to discuss yor requirements.
United States of America