DUBLIN–(BUSINESS WIRE)–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.
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 Critical 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/ykoox4
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For
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1-800-526-8630
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Related
Topics: Animal
Healthcare/Veterinary