Author Archive | s_mccully


Non-Interventional Studies – What is the Biggest Challenge?

Non-Interventional Studies… Q. What is the Biggest Challenge? A. Working out the regulatory requirements for your study! Finding out what’s needed to run a non-interventional study shouldn’t be difficult, but it is! We’ve taken the pain out of that process by collecting the relevant information per country and per study type and captured this in […]

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New FDA Guidance on Informed Consent Waiver for Clinical Investigations Involving No More than Minimal Risk

FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv Health Clinical Spain S.L. In July 2017, FDA issued this guidance for immediate implementation. Link to the Guidance: The […]

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6th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology – July 2017

The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website and includes revisions, amendments and new references in all the chapters. Revisions were performed by the authors, in collaboration with the editorial group. External comments received were also considered. Due to developments in some areas or need for restructuring and […]

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New FDA Draft Guidance – Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11

The FDA  released a new draft guidance document on 21 June 2017.  Comments should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. >>>Link to Draft Guidance Document: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 […]

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How far do the medical device rules affect health-related apps?

Source: Osborne Clarke It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing.  But deciding exactly when software will be categorised as such a device is not so straightforward.  An Opinion from an Advocate General […]

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Survey – Pragmatic Clinical Trials

It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting them and what challenges are they facing? Please take this short anonymous survey […]

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RWE – What are the Opportunities across the product life cycle?

What are the real-world evidence tools and how can they support decision making? EMA-EuropaBio Info Day – 22nd November 2016 Dr Alison Cave, Principal Scientific Administrator, Pharmacovigilance and Epidemiology Department, EMA [View Slide Deck…] RWE – What are the Opportunities across the product life cycle? Medicines Development Population-based databases to characterize frequency and distribution of […]

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