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
Speakers
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.
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.
