September 2019

1. ICH Public Meeting at FDA HQ on ICH E8(R1)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting (31 Oct 2019, at the FDA headquarters) to review the draft E8 Guideline ‘General Considerations for Clinical Trials’. Those interested can attend in person or follow the event via webcast. Details are here. 

2. Implications of Policy 0070 - Summary Article

Julia Forjanic Klapproth and Jo Anne-Marie Blyskal summarise EMA policy 0070 implications for clinical trial document disclosure. They bring the story right up to date with the Brexit preparedness perspective. Read the whole article here.

3. ISCR CORE Reference Workshop

The Indian Society for Clinical Research (ISCR) will present a workshop titled: "Adopting CORE Reference in Writing Disclosure-friendly CSRs" at Stellar Business Park, Sector-62, Noida, India on 11 November 2019 (8:30 am – 6:00 pm).

4. Guidance on medicines and devices regulation if the UK leaves the EU without a deal (including clinical trials)

This no-deal Brexit detailed Guidance is just published. It’s a major update on all aspects of medicines and devices regulation in the UK in the event of a no-deal Brexit, including Section 3 ‘Clinical trials of IMPs’.

Summary of Section 3 (which should not stop you reading the detail for yourselves):
• Clinical trials will continue under existing approvals - both regulatory and ethics
• Trial Sponsor location – separate registration of a UK contact point is NOT necessary. i.e. where trials are pan-EU, legal reps must be based in EU
• EU CTR 536/2014 (not yet in force) will not be incorporated into UK law on Brexit, but UK will align where possible when CTR comes into force
• QP certificates done in EU will be recognized
• Import of IMP into UK will need a manufacturers license – Sponsors will have 12 months to comply post-Brexit
• All SUSAR reports to MHRA for UK events – to go through new UK portal (SUSAR submission registration link is provided in Section 3.7)
• UK can still participate in multinational trials
• Public disclosure: In the short term, UK to continue to use EudraCT and clinical (and other established national registries) for postings. However, when new EU portal goes live (as part of new CTR), UK will have its own hub.
There is also regulatory information relating to medicines and devices in other sections of this Guidance that will also affect our work.

5. Register to make submissions to the MHRA (if no-deal Brexit)

This is an important page for your organisations to be aware of. It is the main page on which you register to make submissions to MHRA in the event of a no-deal Brexit. The page includes links to 'Gaining Access for MHRA Submissions' and a link to register to use the Vigilance System. 

6. Webinar: Data synthesis provides a reliable way to share clinical trial data for secondary analysis while protecting participant privacy.

This webinar discusses the generation of synthetic clinical trial data and some applications. Synthetic data can be useful in transparency use cases, and also enables secondary analysis and technology evaluation. Register here.

7. FDA HHS Workshop: Privacy and Health Research in a Data-Driven World

The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is hosting its 2nd Annual Exploratory Workshop on September 19, 2019. The title of the Workshop is Privacy and Health Research in a Data-Driven World. It will be webcast live and recorded, and is available free of charge.
The Workshop will explore issues around conceptions of privacy, ways to protect data confidentiality, and how IRBs and review bodies can learn more about protections and ethical oversight of important research.
Sessions will include:

• Is Privacy a Casualty of Advancing Research?
• Approaches to Protecting Privacy and Confidentiality
• Protecting Privacy and Confidentiality: A Shared Responsibility

Read the draft agenda and more information.

8. Health Canada's Publication of Clinical Data Gains Pace

After an initially slow start, Health Canada have started to pick up the pace on their clinical data made public. In the last 2 months, data has been published on 8 drugs and 3 Class III devices.  This RAPS article provides a good summary. Further HC Clinical information releases are in progress.

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