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.
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; 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.
This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.
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
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.
This course will cover:
Day 1
Day 2
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
Maximum Residue Limits (MRLs) – safety and residue data requirements
MRL dossier: safety file (pharmacology and toxicological studies)
MRL dossier: residue file (metabolism and residue studies)
Pharmacokinetics and bioequivalence
Workshop session
Planning a dossier to contain:
Pharmaceutical development studies
Toxicological, pharmacokinetic, metabolism and residue studies
Pre-clinical and clinical studies
About IPI Academy
Who Are We?
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and attention.
What Do We Do?
With our network of over 1,000 carefully selected and internationally renowned presenters, trainers, consultants, global industry leaders, authors and training partners, the IPI Academy delivers an all-encompassing international skills training and development service.
We specialise in developing the skills and technical expertise of individuals and teams across a diverse range of organisations.
We work closely with large, small, public and private, domestic and international companies to provide solutions across many industries.
We offer many different delivery options
Live online training including 90 minute High Impact courses, 1-3 hour long Masterclasses, 1-,2- or 3-day Focused training courses, and Intensive training courses running over 4 or more days.
Self-paced online learning which can be done in your own time
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E-books relevant to your role or industry
Coaching
Consultancy
In addition, we offer tailored programmes in-house as well as coaching support and event management solutions within global organisations on an international scale.
Our events are designed to be highly practical and interactive, maximising the breadth of our speakers’ experience and knowledge. A particular focus on using hands-on teaching methods including highly specific case studies and examples allow delegates to ‘dry run’ skills and techniques with an industry professional before applying them in your own professional setting.
Why Choose Us?
Our aim is to provide you with the highest quality professional development options within your profession or industry.
Striving to offer the latest topics and cutting-edge information in a variety of ways to suit our customers and their budget
Connecting you to top professionals within your industries to ensure a dynamic and engaging experience
Giving you the best opportunity for learning, engaging, sharing and networking with the very best
We consistently score highly on customer satisfaction
We have a dedicated team behind the scenes to ensure our customer service exceeds your expectations
Our Partners In Making This Happen
We seek to work with companies that share the same passion as us: delivering top quality training and information across the globe.
Some of our partners include:
Falconbury and Management Forum who have consistently delivered exceptional training services. For many years they have put on professional conferences, seminars and in-house courses in a range of sectors including life sciences, intellectual property, legal, HR and management – all with an astounding customer satisfaction rate.
Thorogood Publishing is an independent publisher of books for business. They aim to publish authors with a proven track record in their fields, and the books produced are accessible, practical and of immediate value.
Partnerships between pharmaceutical companies are now commonplace for a range of activities. To ensure that all parties meet their obligations, many agreements need to include pharmacovigilance wording, either as part of contracts or more frequently as separate documents.
This module provides advanced training over five days on the principles of drug safety assessment (pharmacovigilance, PV), pharmacoepidemiology (PEp) and pharmacoeconomics (PEc) applied during the development and marketing of medicines.
Pharmacovigilance managers and PV professionals with a number of years of experience.
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