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Annual report from the MHRA on the regulation of medicines advertising to promote transparency.
Highlights of the committee meeting.
CVMP opinions on veterinary medicinal products
This guidance provides a framework to facilitate the management of post approval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and is composed of a Core Guideline and two Annexes.
Notify the MHRA about a clinical investigation for a medical device - update to guidance concerning Northern Ireland.
#Red4Research Day on Friday 18th June 2021
We would like to inform you that the European Commission has launched a public consultation on European Health Data Space (EHDS), which aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policy-making and legislation.
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development, which could have a positive impact on vaccine confidence.
MHRA have produced a new 'Guidance on the licensing of biosimilar products'.
The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) is currently undergoing a major revision.