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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EU – List of Products Granted Eligibility to PRIME

PRIME (PRIority MEdicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can […]

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Germany – Impact of Amendment of the German Drug Act on NIS

The German Bundestag adopts Fourth Act on the Amendment of the German Drug Act and Other Provisions Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health The 4th law on the amendment of the German Drug Act came into force on December 24, 2016 (G. v. 20.12.2016 BGBl. I S. 3048 (Nr. 63)). […]

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Research Involving Human Beings in France – Impact on NIS

Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health An important modification of the French research law framework occurred in November 2016 with the coming into force of decree No. 2016-1537.  The law describes the modalities for research involving humans and eventually adds ‘non-interventional research’ to the research law framework. The most recent […]

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Three dimensional map of South Korea in South Korean flag colors.

South Korea – MFDS’ Major Pharmaceutical Policy Initiatives for 2017

The Ministry of Food and Drug Safety of Korea (the “MFDS“) announced major policy initiatives in the pharmaceutical sector for 2017 on January 9, 2017 (the “Policy Initiative”) With respect to pharmaceuticals, the MFDS declared plans to select the “Enhancement of the Safety Management System” as its main priority and thereby strengthen user-centered safety management as […]

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Portugal: Changes in the legal framework of advertising of medicines and medical devices

Rules that govern advertising and promotion activities of medicines and medical devices in Portugal have been changed recently by the enactment of Decree-Law 5/2017 of 6 January (“Decree-Law 5/2017”). This new legal act establishes principles that shall be accomplished by marketing authorization holders and distributors of medicines, as well as manufacturers and distributors of medical […]

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Sweden Reviews Financing and Pricing

In mid-November 2016 the government issued directives to review the pricing and reimbursement system and the national financing system for medicinal products. The government declared that the existing system is complex and complicated and must be improved in order to operate a modern healthcare system. Among other things, the review seeks to find a clear […]

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FDA Announces New Draft Guidances on Medical Product Communications (FDAMA 114)

18 January 2017 – the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.  These draft guidance documents provide clarity on FDAs position based on the […]

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French Sunshine Obligations Clarified and Extended

The long-awaited decree that clarifies the French “Sunshine” obligations was recently published in the French Official Gazette, and it brings about some important changes to the existing transparency requirements that apply in the life sciences sector in France. Indeed, pursuant to French Decree no. 2016-1939 of December 28, 2016 (“Sunshine Regulations”), health care companies (“HCCs”) […]

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