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 chuck_ltd | 5 Aug, 2016 | CHCUK News & Articles, HTA, NIS, Pragmatic Trials, Real Word Evidence
The ‘Real world evidence’ workshop was held on 17 September 2015 as part of the Academy’s FORUM programme. It brought together participants from across industry, regulatory, academia and policy to explore the acceptability of real world evidence in regulatory and...
by chuck_ltd | 24 Mar, 2016 | CHCUK News & Articles, HTA, News, Real Word Evidence, Reimbursement
Date: 16/02/2016 Purpose of the meeting DG SANTE was invited to the EFPIA Working Group on HTA. The purpose of the meeting was to present the EU activities on HTA and to discuss the possible ways of HTA collaboration in the area of relative efficacy (REA) in view of...
by chuck_ltd | 24 Mar, 2016 | CHCUK News & Articles, Digital Health Technology, HTA, News, Real Word Evidence
Kick-off meeting of the third HTA Joint Action: 3 March 2016 The kick-off meeting of “EUNetHTA 3” (2016-2019) – the third Joint Action which aims to pave the way for sustainable cooperation on Health Technology Assessment (HTA) in Europe takes place in Amsterdam...
by chuck_ltd | 24 Feb, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, HTA, News, NIS, Pragmatic Trials, Real Word Evidence, Webinar
Regulators, Health Technology Assessment (HTA) agencies and health care payers are increasingly demanding Real World Evidence (RWE) to support both initial product approval/reimbursement as well as continuing approval/reimbursement over a product’s life cycle....
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 | 26 Nov, 2015 | CHCUK News & Articles, HTA, News, NIS, Pragmatic Trials, Real Word Evidence
Observational (OBS), Pragmatic (PRA), and Indirect (IND) Methodologies for Comparative / Relative Effectiveness (RE) and Benefit-Risk (BR) Analyses Dr Florian Eichmann, Kathrin Kreyenberg – Late Stage Business Unit, inVentiv Health Clinical, Munich, Germany...
by chuck_ltd | 28 Oct, 2015 | CHCUK News & Articles, HTA, News, Publication Guidelines
Rationale The Codes have been revised to provide a clearer flow of information, and there are now fewer documents that establishments need to refer to. The Codes of Practice on Disposal (Code 5) and Import and Export (Code 8) have been incorporated into the sector...
by chuck_ltd | 14 Oct, 2015 | CHCUK News & Articles, HTA, Medical Apps, News, NIS
Article by: Florian Eichmann, PhD, Principal Late Stage, Scientific Affairs and Real World Evidence, inVentiv Health Clinical, Munich, German Regulators and Health Technology Assessment (HTA) agencies – and thus manufacturers and research stakeholders –...
by chuck_ltd | 25 Aug, 2014 | HTA, NIS
Using data from GP records in the Clinical Practice Research Datalink (CPRD), health researchers from the London School of Hygiene and Tropical Medicine conducted the largest study of its kind into the link between obesity and cancer. Overweight and obesity linked to...
by chuck_ltd | 14 May, 2014 | CHCUK News & Articles, HTA
Guidance to facilitate early dialogue between regulators, health-technology-assessment bodies and medicines developers The European Medicines Agency (EMA) has published today for public consultation best practice guidance for pilot parallel scientific advice...
