by Mark Heinemann | 6 Feb, 2020 | CHCUK News & Articles, Consultation, Data Privacy, News, NIS, PASS, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Intelligence
2010 to 2019: BFARM / PEI Guidelines on Drug Observation Studies (AWB) and Voluntary Post-Authorization Safety Studies (PASS) Updated New recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute on observational drug...
by Syneos Health_1 | 18 Jul, 2019 | Consultation, Real Word Evidence, RWD
Summary NICE welcomes the opportunity to continue our well-established practice of translating evidence into practical guidance and advice, and to expand our methods and processes to enable more extensive and effective use of broader sources of data. We acknowledge...
by Syneos Health_1 | 30 May, 2019 | CHCUK News & Articles, Consultation, Real Word Evidence, Real World Research Design, Regulatory Grade RWE
May 2019 – the Center for Drug Evaluation (China) has released a draft document for public review on “Key Considerations in Using Real-World Evidence to Support Drug Development” Background and Purpose Randomized Controlled Trials (RCTs) are...
by Syneos Health_1 | 28 May, 2019 | Consultation, NIS, Real Word Evidence, Safety Management
ICH has released a new E series guideline for consultation: ICH E19 – Optimisation of Safety Data Collection Objective of the Guideline This Guideline is intended to provide internationally harmonised guidance on an optimised approach to safety data collection...
by Syneos Health_1 | 10 May, 2019 | 21 Century Cures Act, Consultation, Cures Act, FDA Guidance, Real Word Evidence, Regulatory Grade RWE
This draft FDA guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA...
by Syneos Health_1 | 8 May, 2019 | Consultation, FDA Guidance, Rare Diseases, Real Word Evidence
The FDA has published a draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.” The purpose of this draft guidance (January 2019) is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in...
by Syneos Health_1 | 8 May, 2019 | Consultation, FDA Guidance, Rare Diseases, Registry
The Food and Drug Administration (FDA or Agency) has announced (27 March 2019) the availability of a draft guidance for industry entitled “Rare Diseases: Natural History Studies for Drug Development.” FDA is publishing this draft guidance to help inform the design and...
by Syneos Health_1 | 11 Dec, 2018 | 21 Century Cures Act, Consultation, Cures Act
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations (21 CFR Parts 50, 312, and 812) to implement a provision of the 21st Century Cures Act (Cures Act). This proposed rule, if finalized, would allow an exception from the requirement...
by Syneos Health_1 | 19 Nov, 2018 | 21 Century Cures Act, CHCUK News & Articles, Consultation, Real Word Evidence, Registry, Regulatory Grade RWE
Use of patient disease registries for regulatory purposes (new) On 8 November 2018 the EMA cross-committee task force published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes:...
by chuck_ltd | 12 Feb, 2017 | 21 Century Cures Act, Consultation, FDAMA114, Uncategorized
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...
by chuck_ltd | 23 Jan, 2017 | CHCUK News & Articles, Consultation, GCP, News, NIS, Real Word Evidence
ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, Consultation, GVP
Draft guideline on good pharmacovigilance practices (GVP) – Module IX – Signal management (Rev. 1) Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR,...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, Consultation, GVP, News, NIS
Draft guideline on good pharmacovigilance practices (GVP) – Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2) This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter...
by chuck_ltd | 16 Feb, 2016 | CHCUK News & Articles, Consultation, Cybersecurity, Digital Health Technology
Is Your Medical Device Cybersecure? FDA Issues Draft Guidance on Postmarket Cybersecurity in Medical Devices Recently, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining the agency’s recommendations for Postmarket Management of Cybersecurity...
by chuck_ltd | 16 Dec, 2015 | CHCUK News & Articles, Consultation, GVP, News, NIS, Real Word Evidence, Registry, Virtual Clinical Research
Latest EMA GVP (XVI) Module Update The final Addendum I to Module XVI on educational materials is published, taking into account comments from the public consultation. Further, revision 1 of Module XV on safety communication, with revision 1 of the template for Direct...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, Consultation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects In 2010 the Executive Committee of CIOMS decided to revise the CIOMS Ethical Guidelines for Biomedical Research. The document was last revised in 2002. Since then,...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, Consultation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Introduction (Highlights from the ENCePP Plenary Meeting, 24 November 2015) Xavier Kurz set the scene by presenting a brief introduction highlighting ENCePP’s potential role and contribution so far to the regulatory need for continuous monitoring and investigation of...
by chuck_ltd | 20 Nov, 2015 | CHCUK News & Articles, Consultation, News, NIS, Pragmatic Trials, Real Word Evidence
Proposed Revisions to Modernize, Strengthen, and make more Effective the Federal Policy for the Protection of Human Subjects Various US departments and agencies propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection...
by chuck_ltd | 18 Nov, 2015 | CHCUK News & Articles, Consultation, GCP, News
Public consultations on NOTICE FROM THE COMMISSION ON ASPECTS OF THE APPLICATION OF ARTICLE 3, 5 AND 7 OF REGULATION (EC) NO 141/2000 ON ORPHAN MEDICINAL PRODUCTS The European Commission is proposing to review the 2003 Communication on orphan medicinal products to...
by chuck_ltd | 18 Nov, 2015 | CHCUK News & Articles, Consultation, GCP
The (CFDA) has released for public comment proposed revisions to the good clinical practice (GCP) rules for pharmaceutical clinical studies. The proposed revisions, if eventually promulgated, will be the first revision since the enactment of the existing GCP rules in...
