- Home
- Veterinary Pharmaceutical Submissions in the EU
Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.
Details
Course overview
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; detailed and critical summaries; 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 the detailed and critical summaries on safety
- Consider the pre-clinical and clinical requirements
- Take away regulatory strategies and procedures
- Acquire the skills to write the regulatory submission
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 registrations of veterinary medicines.
Programme
EU regulatory framework
- Understanding the regulatory objectives
- EU legal framework
- Legal base of regulatory procedures and dossier requirements
Part II: Pharmaceutical data requirements
- Formulation and analytical data
- Manufacturing process
- Stability studies
Workshop session
Planning a dossier to contain:
- Pharmaceutical development studies
- Toxicological, pharmacokinetic, metabolism and residue studies
- Pre-clinical and clinical studies
Part IIIA: Consumer and environmental safety data requirements
- The toxicological package
- Maximum residue limits dossier: safety file
- Part IIIA of the marketing authorisation application
User safety risk assessment
- Reviewing toxicology studies
- Setting the scenario
- Risk assessment and management
Pharmacokinetics and bioequivalence
Environmental risk assessment
- Phase I and II assessments
Part IIIB: Residues
- Metabolism and residue studies
- Maximum residue limits dossier: residues file
- Withdrawal period
- Part IIIB of the marketing authorisation application
Detailed and critical summaries on safety and residues
Part IV: Pre-clinical data
- Pharmacodynamics and pharmacokinetics
- Target species tolerance
- Resistance
Part IV: Clinical data and clinical detailed and critical summaries
- Clinical trials
- Clinical detailed and critical summaries
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
Presenters
Dave Parry (More...)
David 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 (More...)
Dr 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.
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
|
9-10 Jun 2022 Live webinar 09:00-16:30 UK (London) |
|||
|
9-10 Jun 2022 Live webinar 09:00-16:30 UK (London) |
GBP 1,199.00 EUR 1,719.00 USD 1,942.00 + VAT @ 20.00% |
Enrol now
to attend Live webinar |
|
|
13-14 Dec 2022 Live webinar 09:00-17:00 UK (London) |
|||
|
13-14 Dec 2022 Live webinar 09:00-17:00 UK (London) |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 8 Nov* |
Enrol now
to attend Live webinar |
|
Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.