Early Bird Pricing Now Available - Book Now.More information
Join the community - networking, discussion and more. Open to all.More information
Learn why becoming a member of RQA could be right for you.More information
Could you write an interesting article for the RQA community?More information
Pages dedicated to these focal RQA groups.More information
New Clinical Trials Regulation - EU No. 536/2014 (repealing Directive 2001/20/EC)
EU Commission Directive 2005/28/EC
Commission Directive (EU) 2017/1572
The Medicines for Human Use (Clinical Trials) Regulations 2004 - Statutory Instrument 1031
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 - Statutory Instrument 1928
The Medicines for human Use (Clinical Trials) Amendment (No.2) Regulations 2006 - Statutory Instrument 2984
The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 - Statutory Instrument 941
FDA Regulations relating to GCP and clinical trials
ICH E6 Guidelines for Good Clinical Practice
Medicines for Human Use - Eudralex
MHRA Serious Breaches Guidance
MHRA Good Clinical Practice Guide (Grey Guide)
Click here to view the process which covers types of inspection, routine inspection process flowchart, submissions, what to expect during ruotine inspections, findings and reporting of ruotine inspections and triggered inspections.
US Department of Health and Human Services link to to laws, regulations, and guidelines that govern human subjects research in 104 countries, as well as the standards from a number of international and regional organisations. Click here.
The Japan Society of Quality Assurance (JSQA), the Society of Quality Assurance (SQA) and the RQA have published an agreed Global GCP Auditing Guideline together with supplemental Appendices on a number of specific audit types, effective April 2014. This is a unique, collaborative effort between the three societies aimed at providing our members with guidance and best practice approach to GCP auditing across regions.
Click here for more information (members only)
Click here to view an archived regulations and guidelines document - while this information is not the most current, it may nonetheless be beneficial from a historical perspective.