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 | 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The Food and Drug Administration (FDA or Agency) has announced (27 March 2019) the availability of a draft guidance for industry entitled “Rare Diseases: Natural History Studies for Drug Development.” FDA is publishing this draft guidance to help inform the design and...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 | 8 May, 2019 | 21 Century Cures Act, HTA, Real Word Evidence, Registry
REQueST® tool and its Vision paper are now available for Public Consultation The use of registries is becoming increasingly common in health technology assessment (HTA) and regulation. There is a growing interest in the role of observational data in complementing...
by Syneos Health_1 | 9 Dec, 2018 | 21 Century Cures Act, FDA Guidance, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Grade RWE
It’s here! The long awaited FDA “draft framework for implementation” of the real world evidence program required by Section 3022 of The 21st Century Cures Act (Cures Act) has been published. Framework for FDA’s Real World Evidence Program The Cures Act is...
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 | 9 Apr, 2018 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Registry
Germany – Professional Advice under Section 15 BO Ärzte: Speeding up the Process for Non-Interventional Studies? Author: Mark Heinemann, Principal Regulatory Advisor, CHCUK Consulting German Ethics Committees (ECs) make an important step towards the...
by chuck_ltd | 9 Mar, 2017 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
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 –...
by chuck_ltd | 10 Sep, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, White Paper
White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory...
by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, GVP, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Summary The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices...
by chuck_ltd | 8 Feb, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Reimbursement
February 2016 is expected to see the launch of a single market of medicines in the framework of the Eurasian Economic Union, which may be a game changer in the industry. Currently over 30 draft acts have been adopted, establishing EEU rules and principles for movement...
by chuck_ltd | 26 Jan, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Registry, Virtual Clinical Research
Starting from January 1st 2016 the online-platform BASEC (Buisness Administration System for Ethics Committees) to submit research project to Swiss Ethics Committees is mandatory. Link: https://submissions.swissethics.ch/en/ No submissions or updates outside of BASEC...
by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research
On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”). Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...
by chuck_ltd | 21 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
EMA Public Consultation on – ‘Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations’ Start of public consultation: 21 December 2015 Deadline for comments: 31 May 2016 Provide comments using...
by chuck_ltd | 18 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
The conduct of pharmacoepidemiology studies are regulated by pharmacovigilance legislation which varies by region and country throughout the globe. These regulations and resulting definitions and requirements are summarised in guidance documents for study sponsors and...
by chuck_ltd | 18 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
New ENCePP Guidance on Conducting Systematic Reviews and Meta-Analyses of Completed Comparative Pharmacoepidemiological Studies of Safety Outcomes Annex 1 to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology was adopted by the ENCePP Steering Group...
by chuck_ltd | 17 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
Introduction The fight against corruption is a serious challenge in the pharmaceutical sector in Turkey and worldwide. This is because the state is generally the main buyer of goods and services provided by pharmaceutical companies and healthcare professionals such as...
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 | 14 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Human Rights Day – 10 October Herbert Smith Freehills LLP – Stéphane Brabant Beyond the traditional judicial fora where business enterprises can be challenged for human rights violations, they now also face ‘new judges’ such as NGOs, consumers, financial...
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, HTA, News, NIS, Real Word Evidence, Registry
New EUnetHTA joint action, co-financed by the EC and participating bodies from nearly all EU Member States, is due to start in early 2016. One of the work packages will be dedicated to evidence generation, dealing with the question of early dialogue on initial data...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
Introducing the Observatoire Français de la Sclérose en Plaques (OFSEP), a registry whose objective it is to maintain and expand the cohort of patients with MS in France, to enrich existing clinical data with imaging and medical-economic data and with biological...
