This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP. The meeting will address a typical case study where a practical approach will be made to setting up, running and monitoring clinical trials followed by an audit of these studies to satisfy the stringent requirements seen in Europe. Standard documentation utilised for recording data, performing audits and a typical protocol will be supplied for use in the company attendees’ own laboratories.
Why you should attend
- Understand the regulatory requirements and study design
- Know how to design protocols and apply them
- Take away practical advice on how to set up clinical trials
- Clarify the pharmacovigilance requirements
- Gain a better understanding of data handling and ‘appropriate’ statistics
- Discover how to produce the final report
- Assure quality in laboratory field studies
Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Programme Day One
The Regulatory Requirements and Study Design
- Overview of GCP status covering VICH guidelines
- An indication where trials must comply
- Ethical aspects of GCP in all studies
- Field study vs laboratory studies – regulatory GCP and GLP compliance
- European anomalies
- Project planning and timescales
- Types of trials
- Project design and teamwork
- A case study
Protocol Design and Application
- Protocol production and approval
- Protocol content and special points for inclusion
- A case study
Setting up Clinical Trials – A Practical Case Study
- Case report form design and supportive documentation
- Investigator selection
- Responsibilities of the Monitor and the Principal Investigator
- Test material
- In-life activities
- Study close-out and reporting
- Principal differences between laboratory and field studies
Pharmacovigilance Requirements and Considerations
- Recent regulatory developments
- Impact on clinical studies
17.00 Close of Day One
Programme Day Two
Data Handling and ‘Appropriate’ Statistics*
- Review of the current CVMP statistics guidelines
- Types of data
- Types of statistics
- Evaluation of data
- A case study
Producing the Final Report
- Data and QC
- Archiving data
- A case study
Assuring Quality in Laboratory and Field Studies
- Standard Operating Procedures (SOPs) writing, use and review
- The QA function
- Interaction between GLP, GCP and GMP in veterinary studies
- Pre-study involvement
- Protocol review
- Audit planning
- In-life audit
- Sponsor/site trial master file review
Discussion will take place throughout the two days
Ms Marie-Pascale Tiberghien,
Technical marketing activities ,
Marie-Pascale qualified from Lyon Veterinary School, France. She holds an MSc in Applied Statistics from Sheffield Hallam University, 1997. She has worked in the veterinary pharmaceutical industry for most of her career, notably in Clinical Development and later in Marketing and Technical Services. She is currently based in Monheim, Germany, with Bayer Animal Health Global Marketing and is responsible for technical marketing activities for new products intended for use in food-producing animals.
Ms Sue Lester,
Founding Director ,
Sue Lester qualified in Biology and Chemistry and worked in a veterinary laboratory before joining the Animal Health industry where she has now worked for nearly 20 years. She rapidly became a leading international expert in Quality Assurance (GCPv, GLP, and GMP). She has a Diploma in Research Quality Assurance, and is a Fellow of the British Association of Research Quality Assurance (BARQA). She was a founding member of the BARQA Animal Health Committee, and is the author of a chapter on GCPv in the textbook “Veterinary Clinical Trials from Concept to Completion”. Having been employed by four companies Sue was a Founding Director of Triveritas, a leading international contractor to the Animal Health industry. She is responsible for all aspects of Quality Assurance.
Dr Julian Braidwood,
Veterinary Surgeon and R&D Director ,
Dr 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.
He 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 formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA.
Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.
Personnel involved in the Animal Health industry who are responsible for monitoring Clinical Veterinary Studies, setting up protocols and studies, both in the Laboratory and Field environment to comply with Good Clinical Practice guidelines. It will be immediately relevant to Quality Assurance professionals who are required to audit these types of studies. Clinical Project Managers and Regulatory Affairs personnel will also benefit from this course by gaining an overview of the conduct of studies, the regulatory requirements and European.
Venue to be announced shortly.