DUBLIN, May 21, 2019 /PRNewswire/ -- The "Veterinary Pharmaceutical Submissions in the EU" conference has been added to ResearchAndMarkets.com's offering.
This course will take participants 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.
This practical two-day In-house course will take participants through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product for which a marketing authorisation is sought 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 course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire regulatory dossier for a veterinary medicinal product in the European Union.
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 Safety' Detailed and Critcal Summary
- Consider the Pre-Clinical and Clinical Requirements
- Take Away Regulatory Strategies and Procedures
- Know How to Write the Regulatory Submission
Who Should Attend:
Personnel working in the following departments: Regulatory Affairs, Research and Development and Clinical Trials and Marketing. It will also be valuable to those seeking to review special problems encountered in the registrations of veterinary medicines. There will be ample opportunity for discussion during the proceedings.
Agenda:
Programme Day One
09.30 Introduction and Objectives of the course
09.45 EU Regulatory Framework
- Understanding the regulatory objectives
- EU legal framework
- Legal base of regulatory procedures and dossier requirements
10.45 Refreshments
11.00 Part II: Pharmaceutical Data Requirements
- Formulation and analytical data
- Manufacturing process
- Stability Studies
12.15 Discussion
12.30 Lunch
13.30 Workshop session
Planning a dossier to contain:
- Pharmaceutical development studies
- Toxicological, pharmacokinetic, metabolism and residue studies
- Pre-clinical and clinical studies
14.45 Part IIIA: Consumer and Environmental Safety Data Requirements
- The Toxicological Package
- Maximum Residue Limits dossier: Safety File
- Part IIIA of the Marketing Authorisation Application
15.15 User Safety Risk Assessment
- Reviewing toxicology studies
- Setting the scenario
- Risk assessment and management
15.45 Refreshments
16.00 Pharmacokinetics and Bioequivalence
17.00 End of Day One
Programme Day Two
09.00 Environmental Risk Assessment
- Phase I and II Assessments
09.30 Part IIIB Residues
- Metabolism and residue studies
- Maximum Residue Limits dossier: Residues File
- Withdrawal period
- Part IIIB of the Marketing Authorisation Application
10.15 Safety and Residues' Detailed and Critical Summaries
10.30 Refreshments
10.45 Part IV Pre-Clinical Data
- Pharmacodynamics and pharmacokinetics
- Target species tolerance
- Resistance
11.15 Part IV Clinical Data and Clinical' Detailed and Critical Summary
- Clinical trials
- Clinical Detailed and Critical Summary
11.45 EU Regulatory Strategies and Procedures
- Full and abbreviated applications
- Generic applications
- Centralised Procedure
- Decentralised, MRP and National Procedures
12.30 Lunch
14.00 Workshop Session
15.00 Refreshments
15.15 Workshop Presentations
- Presentation by each team
- Review and discussion
15.45 Writing the Regulatory Submission
- Writing the dossier
- Summary of Product Characteristics and labelling
- Working with writers of Detailed and Critical Summaries
16.45 Discussion
17.00 End of Course
For more information about this conference visit https://www.researchandmarkets.com/r/hct0l7
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
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Research and Markets
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SOURCE Research and Markets
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