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Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
21-25 Jun 2021
Details
Course overview
This intensive five-day course provides a thorough understanding of how to develop a veterinary medicine in the EU and USA.
The development of a veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with different scientific training and a wide range of skills. Everyone involved must be aware of the main stages in the development programme and be able to relate his or her responsibilities to the expertise and needs of the scientists and commercial members of the team. Furthermore, different approaches taken by the regulatory authorities in the EU and the USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both regions.
The event 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 participants through all the stages in the development of a veterinary medicinal product for which a marketing authorisation is sought in the EU and the USA. Presentations will cover pharmaceutical and process development, toxicological, pharmacological, residues and environmental studies, safety risk assessments, clinical development, regulatory and marketing input and project management.
Gain a comprehensive understanding of the processes for the EU and USA, including:
- EU and US regulatory frameworks, strategies and procedures n 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 n EU and US target animal safety
- Minor use and minor species (MUMS)
- Writing and managing regulatory submissions
Who should attend?
This course has been designed for anyone who has limited experience in only one of the disciplines in veterinary medicine development, such as pharmaceutical or analytical development, clinical trials, regulatory affairs or quality assurance. Anyone learning the role of project manager, as well as more experienced personnel seeking to review special problems encountered in product development, will benefit from the comprehensive programme delivered by experienced professionals.
Previous delegates who have benefited from this course include clinical scientists, pharmaceutical scientists, marketing managers and personnel from regulatory affairs, R&D and development.
Programme
Day 1 09:00 - 15:00 (UTC)
EU regulatory framework for regulation of veterinary medicines
- What is the EU?
- EU legal framework for regulation of veterinary medicines
- Legal base of procedures and data requirements
US regulatory framework for regulation of veterinary drugs
- Current governing laws and regulations
- Federal agency jurisdictions
EU and USA: differences and similarities
- INAD and NAD in USA
- Phased submission in USA vs marketing authorisation application in EU
- EU MRLs vs US HFS section
- EU renewal, variations, extensions vs US supplements
- EU certificate of suitability and EDMFs vs US DMFs
- Different requirements for user safety and environmental risk assessments
The global development programmes
- Requirements for EU
- Requirements for USA
- Achieving a global development programme
USA regulatory strategies and procedures
- Applications for NCEs and supplements
- Generic drug applications
EU regulatory strategies and procedures
- Full and abbreviated applications
- Generic applications
- Centralised procedure
- Decentralised, MRP and national procedures
Day 2 09:00 - 15:15 (UTC)
MRLs Part A safety and MAA Part IIIA
- The toxicological data requirements
- Determining the NOEL and ADI
USA FDA approach to HFS studies
- Toxicology studies
- Margins of safety
MRLs Part B residues and MAA Part IIIB
- ‘Hot’ and ‘cold’ residue studies
- How to determine maximum residue limits
- Analytical methods for residues
- Determining the withdrawal period
FDA evaluation of consumer safety
- Human food technical safety section
- Residue issues
Workshop - session 1
Day 3 09:00 - 14:45 (UTC)
Environmental risk assessment Phases I and II
- Critical evaluation of your data package
- Phase I assessment
- Refining risk assessment
- Phase II assessment Tiers A and B
- What to do if risk assessment gives cause for concern
User safety risk assessment in the EU
- Reviewing toxicology studies
- Setting the scenario
- Risk assessment and management
Pharmacokinetics and bioequivalence
- ADME studies
- Bioequivalence
Workshop - session 2
Day 4 09:00 - 14:45 (UTC)
EU and US clinical development
- Dose selection
- Field studies
- VICH guidelines
- Claim-driven approach in US
- Protocol review and concurrence with CVM
- Value of VICH guidance
EU and US target animal safety
- Pivotal target animal safety studies
- Filed safety studies
- New VICH guideline on TAS
Minor use and minor species (MUMS)
- MUMS approaches in EU and USA
- What are minor uses?
- What are minor species?
- Approaches to preparation of clinical data
Workshop - session 3
Day 5 09:00 - 14:45 (UTC)
Workshop - presentations
Pharmaceutical development and the CMC package
- Characterising the active substance
- Formulation development
- Analytical development and setting specifications
- Process scale-up and validation
- Stability studies and shelf life
Managing the USA regulatory submission
- Systems of review at CVM
- Team interaction
- Company and regulator interactions
Writing and managing the EU regulatory submission
- Writing the marketing authorisation application
- Summary of product characteristics and labelling
- Working with writers on detailed and critical summaries in the EU
- Pre-submission advice and oral hearings
Presenters
Julian Braidwood (More...)
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.
David Petrick (More...)
Dr David Petrick has over 30 years’ experience in bringing novel animal health products to the marketplace. During his professional career he has worked in Regulatory Affairs and Product Development for both American Cyanamid Company and Schering-Plough Animal Health.
In 2004 he founded the Delta Consortium Regulatory Consulting Limited, serving as a consultant in Regulatory Affairs for animal health companies. In 2009 he joined Triveritas and was a part of the opening of Triveritas, USA. In 2004 Dr Petrick joined Velcera, a venture capital funded animal health company and was the Executive Vice President of Research Development and Regulatory Affairs. Velcera was sold to a major pharmaceutical company in 2010.
He holds a degree in veterinary medicine from the University of Pennsylvania, and a law degree from Seton Hall University. He is a member of the American Veterinary Medical Association, the American Bar Association, the New Jersey Bar Association and the New Jersey Bar.
Book now
Book now
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21-25 Jun 2021 Live webinar |
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21-25 Jun 2021 Live webinar |
GBP 1,999.00 EUR 2,799.00 USD 3,118.00 + VAT @ 20.00% |
Enrol now Limited places to attend Live webinar |
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