Practical Implementation of GCP in Veterinary Field Studies Seminar: Understand the Regulatory Requirements and Study Design - London, United Kingdom - October 23-24, 2019

News provided by

May 31, 2019, 17:00 ET

DUBLIN, May 31, 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

Speakers:

Marie-Pascale Tiberghien
Technical marketing activities
Bayer

Sue Lester
Founding Director
Triveritas

Julian Braidwood
Veterinary Surgeon and R&D Director
Triveritas

For more information about this conference visit https://www.researchandmarkets.com/r/u3rb6d

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