Animal Health Summer School - Working Through Veterinary Drug Development in the EU and USA
Course
In The Rembrandt Hotel, London
*Indicative price
Original amount in GBP:
£ 2,950 £ 2,999
Description
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Type
Practical seminar
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Level
Intermediate
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Location
The rembrandt hotel, london
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Class hours
8h
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Duration
5 Days
This course provides a comprehensive understanding of how to develop a veterinary medicine in the EU and USA. Different approaches taken by the regulatory authorities in the European Union and the USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both the American and European regions.
Important information
Documents
- WORKING THROUGH VETERINARY DRUG DEVELOPMENT IN THE EU AND USA
Facilities
Location
Start date
Start date
About this course
Gain a comprehensive understanding of the processes for the EU and USA, including:
EU and US regulatory frameworks, strategies and procedures
MRLs Parts A & B; MAA Parts IIIA & IIIB
US FDA approach to HFS Studies
User safety risk assessment in the EU
Planning pre-clinical and clinical development
Environmental risk assessment phases I and II
EU and US target animal safety
Minor Use and Minor Species (MUMS)
Writing and managing regulatory submissions
Anyone with limited experience in only one of the disciplines in veterinary medicine development, such as:
Pharmaceutical or analytical development
Clinical trials
Regulatory affairs
Quality assurance
Anyone learning the role of project manager
Experienced personnel seeking to review special problems in product development
Previous delegates include:
Clinical and pharmaceutical scientists
Regulatory affairs
R&D
Marketing managers
Reviews
Subjects
- Veterinary
- Veterinary Medicine
- School
- Drug Development
- Regulatory Compliance
- EU Regulations
- US government
- Animal Care
- Animal Nutrition
- Management
Teachers and trainers (1)
Julian Braidwood
Managing Director, Triveritas, UK
Course programme
This course provides a comprehensive understanding of how to develop a veterinary medicine in the EU and USA. Different approaches taken by the regulatory authorities in the European Union and the USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both the American and European regions.
This course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations and regulatory management are brought together in the development programme. It will take the participants through all the stages in the development of a veterinary medicinal product for which a marketing authorisation is sought in the European Union and the USA.
An important part of the course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire development programme.
WHO SHOULD ATTEND- Anyone with limited experience in only one of the disciplines in veterinary medicine development, such as:
- Pharmaceutical or analytical development
- Clinical trials
- Regulatory affairs
- Quality assurance
- Anyone learning the role of project manager
- Experienced personnel seeking to review special problems in product development
- Previous delegates include:
- Clinical and pharmaceutical scientists
- Regulatory affairs
- R&D
- Marketing managers
Gain a comprehensive understanding of the processes for the EU and USA, including:
- EU and US regulatory frameworks, strategies and procedures
- MRLs Parts A & B; MAA Parts IIIA & IIIB
- US FDA approach to HFS Studies
- User safety risk assessment in the EU
- Planning pre-clinical and clinical development
- Environmental risk assessment phases I and II
- EU and US target animal safety
- Minor Use and Minor Species (MUMS)
- Writing and managing regulatory submissions
Animal Health Summer School - Working Through Veterinary Drug Development in the EU and USA
*Indicative price
Original amount in GBP:
£ 2,950 £ 2,999