All our courses. 12 months access. One flat fee.More Information
The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting to review its draft E8 (R1) Guideline ‘General Considerations for Clinical Trials’. EMA is encouraging its stakeholders to register for this meeting, which will be held on 31 October 2019 at the United States Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, United States of America. Participants will be able to attend in person or via webcast.
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US.
The FDA has recently added three new questions to its Q&A section on cGMP in the Quality Control Laboratory (chromatography systems and describe FDA's perception of basic cGMP principles in chromatographic procedures).
MHRA Blog post by Tracy Moore, 8th August.
Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal - Updated 8 August 2019
Dr Ian Hudson, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) spoke with Viveka Roychowdhury on how the Agency is working with pharmaceutical companies to increase compliance with Good Manufacturing Practices (GMP) as well as preparing for Brexit and beyond. Read the full article.
Detailed guidance on advertising and promoting medicines - updated 12th August 2019.
The first edition of the EMA's 'What’s new in Pharmacovigilance? QPPV UPDATE' is available.
New MHRA Blog Post on eHRs: as you will be aware, in the UK there is a national NHS initiative to replace patients’ paper medical records with electronic health records (EHRs). Although a national initiative, trusts are implementing this locally with different service providers. At several trusts this consists of scanning all written records into the EHR and destroying original source documents (both historic records and current visits).
BP and USP MoU formalise partnership to strengthen quality of medicines and public health