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Stuart McCully
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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 of the Court of Justice of the European Union (CJEU) looks set to provide welcome clarity on this issue.

#CHCUK #EU #Health-Related Apps #inVentiv Health #Medical Device Apps #Medical Device Regulations #Medical Device Software #Osborne Clarke #Stuart McCully

http://www.b2s.pm/XIe61e
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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,

#21 Century Cures Act #CHCUK #Cures Act #EU Clinical Trials Regulation #inVentiv Health #inVentiv Health Clinical #McCully #PCTs #Pragmatic Clinical Trials #Regulation EU/536/2014 #Stuart McCully #Survey

http://www.b2s.pm/W6beVz
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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,

#CHCUK #Dr Alison Cave #EMA #EMA Strategy on Registries #EU #Europe #McCully #Real World Evidence #Registries #RWE #RWE - What are the Opportunities across the product life cycle? #Stuart McCully

http://www.b2s.pm/zGkya5
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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 reach patients earlier.

#CHCUK #Early Access #EMA #EU #Europe #Market Access #McCully #PRIME #Priotity Medicines #Stuart McCully #unmet medical need

http://www.b2s.pm/6hH9MD
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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)).

#“Anwendungsbeobachtungen” (also called AWB) #CHCUK #drug use observation studies #EU #Germany #inVentiv Health #Mark Heinemann #McCully #NIS #Non-Interventional Studies #RWE #RWE and Insights #Stuart McCully #The 4th law on the amendment of the German Drug Act

http://www.b2s.pm/nG4Ain
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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.

#CHCUK #Decree No. 2016-1537 #Europe #France #inVentiv Health #Mark Heinemann #NIS #NIS Considerations #Non-Interventional Studies #research involving human beings #RWE #RWE and Insights #Stuart McCully

http://www.b2s.pm/2KRg93
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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 well as to offer support in bolstering international

#CHCUK #Enhancement of the Safety Management System #Jiyul Yoo #Lexology #McCully #MFDS #MFDS’ Major Pharmaceutical Policy Initiatives for 2017 #South Korea #Stuart McCully #Yoon & Yang LLC #Young Sun Cho

http://www.b2s.pm/YQS0uy
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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,

#advertising and promotion activities of medicines and medical devices #Advertising of Medicines #CHCUK #Decree-Law 5/2017 #Decree-Law 5/2017 of 6 January #EU #Global Compliance News #McCully #Portugal #Rita Roque de Pinho #Stuart McCully

http://www.b2s.pm/Agf91b
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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.

#Advokatfirman Lindahl #Annie Kabala #CHCUK #EU #Jonas Löfgren #Lexology #McCully #Pricing and reimbursement system #Stuart McCully #Sweden

http://www.b2s.pm/g4aCRU
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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 changes to FDAMA144 implemented through Section 3037 of the 21st Century Act.

#21 Century Cures Act #CHCUK #Cures Act #Draft Guidance for Industry #FDA #FDAMA114 #McCully #Stuart McCully #US #USA

http://www.b2s.pm/Us5Ak1
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