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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
Presenter
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.
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6-7 Dec 2021 Live webinar |
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6-7 Dec 2021 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 25 Oct* |
Enrol now
to attend Live webinar |
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8-9 Dec 2021 Face-to-face, (venue not yet confirmed) |
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8-9 Dec 2021 Face-to-face (venue not yet confirmed) |
GBP 1,399 1,199 EUR 1,959 1,679 USD 2,182 1,870 Until 27 Oct* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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* Note the early booking discount cannot be combined with any other offers or promotional code