Obtaining a marketing authorisation for a veterinary medicine can be a costly and time-consuming process and this practical two-day course will equip participants with the key information to achieve a successful application.
The programme will take delegates through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product in the European Union, including the maximum residue limits dossier.
Presentations will cover the regulatory framework; pharmaceutical, toxicological and pharmacological data; safety risk assessments; pre-clinical and clinical data; critical expert reports and regulatory submissions.
An important part of the programme will be devoted to working on case studies in the workshop sessions and there will be ample opportunity for discussion throughout the two days with the expert trainer and fellow professionals.
Benefits of attending
- Understand the EU regulatory framework
- Learn the pharmaceutical data requirements
- Know how to comply with the safety requirements
- Review the user safety risk assessment
- Consider the environmental risk assessment
- Receive guidance on preparing critical expert report
- Consider the pre-clinical and clinical requirements
- Take away regulatory strategies and procedures
- Acquire the skills to write the regulatory submission
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
EU regulatory framework
- Understanding the regulatory objectives
- EU legal framework
- Legal base of regulatory procedures and dossier requirements
Part 2: Pharmaceutical data requirements
- Formulation and analytical data
- Manufacturing process
- Stability studies
Maximum Residue Limits (MRLs) and MA Part 3B residues data
- MRL dossier: safety file and residue file
- Residue depletion studies
- Setting the withdrawal period
Pharmacokinetics and bioequivalence
Workshop session 1
- Planning a dossier to contain:
- Pharmaceutical development studies
- Toxicological, pharmacokinetic, metabolism and residue studies
- Pre-clinical and clinical studies
Day 2
Part 3A of the marketing authorisation (MA) application
- Pharmacology and toxicology studies
- User safety risk assessment
- Setting the scenario
- Risk assessment and management
- Environmental risk assessment
- Phase I and II assessments
Part 4A: Pre-clinical data
- Pharmacodynamics and pharmacokinetics
- Bioequivalence studies
- Resistance
- Dose determination and confirmation
- Target species tolerance
Part 4B: Clinical data
- Clinical trials
EU regulatory strategies and procedures
- Full and abbreviated applications
- Generic applications
- Centralised procedure
- Decentralised, MRP and national procedures
Writing the regulatory submission
- Writing the dossier
- Summary of product characteristics and labelling
- Working with writers of detailed and critical summaries
Course Provider
Dave Parry,
knoell Animal HealthDavid Parry is a chemist with over 14 years of experience in in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with manufacturers in developing formulations and the commercial manufacturing process. Taking advantage of his previous roles in pharmaceutical research and development and process development, David brings a broad range of chemistry, manufacturing and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets and working with contract manufacturing organisations, David is involved with all aspects of regulatory support from early stage development through to post approval product maintenance.
Andrew Hewitt,
Knoell Animal HealthDr Andrew Hewitt is a veterinarian with over 14 years of experience in Veterinary Medicinal Product development in a clinical and regulatory capacity. In his current position as Senior Advisor for Veterinary Product Development at knoell, Andrew manages all aspects of regulatory input in product development and registration, from early proof of concept right through to post authorisation work. Taking advantage of previous his previous role as a clinical practitioner in the UK, and investigator and monitor on clinical trials, Andrew brings a broad range of clinical and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets, Andrew has a particular interest in strategic regulatory planning during product development.
Who Should Attend
Personnel working in the following departments:
- Regulatory affairs
- Research and development
- Clinical trials
- Marketing
The course will also be valuable to those seeking to review special problems encountered in the registration of veterinary medicines.
Location
ADDRESS
Rembrandt Hotel
11 Thurloe Pl,
Kensington
London
SW7 2RS
United Kingdom
DIRECTIONS
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.
