Practical Implementation of GCP in Veterinary Field Studies (London, United Kingdom - April 29-30, 2020)
Sep 19, 2019, 13:15 ET
DUBLIN, Sept. 19, 2019 /PRNewswire/ -- The "Practical Implementation of GCP in Veterinary Field Studies" conference has been added to ResearchAndMarkets.com's offering.
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 Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.
The course 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
Who Should Attend:
- Personnel involved in the animal health industry who are responsible for monitoring clinical veterinary studies and setting up protocols and studies, both in laboratory and field environments, to comply with GCP
- Quality assurance professionals who are required to audit these types of studies
- Clinical project managers and regulatory affairs personnel who will benefit by gaining an overview of the conduct of studies, the regulatory requirements and European perspectives
Agenda:
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
For more information about this conference visit https://www.researchandmarkets.com/r/8jcdol
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected]
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
SOURCE Research and Markets
