Real-World Evidence in Medicine Development Course
[vc_row][vc_column][vc_column_text] The interactive online course Real-World Evidence in Medicine Development starts again on April 16th. Visit their website for more information. (http://www.imi-getreal.eu/Course)[/vc_column_text][/vc_column][/vc_row]
Call for Comments – ATMP guideline on safety and efficacy follow-up and risk management
The revised ATMP guideline on safety and efficacy follow-up and risk management has been released for a 3-month public consultation (deadline of 30th April). EMA would be pleased to receive any HTA comments in respect of the post-authorisation safety and efficacy studies’ endpoints. Please see the links below. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/02/news_detail_002897.jsp&mid=WC0b01ac058004d5c1 Guideline on safety and efficacy follow […]
EUnetHTA Magazine – Winter 2017-2018
Interview with Menno Aarnout/AIM, Partner Profiles: Portugal, Impact: Croatia and Italy, A Patient’s Perspective: Dr. Cees Smit, EMA-EUnetHTA Finalise Joint Work Plan, 2017-2020 winter_2017_magazine_final
An analysis of HTA and reimbursement procedures in EUnetHTA partner countries: final report
An analysis of HTA and reimbursement procedures in EUnetHTA partner countries: final report Background Health technology assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of health technologies. HTA aims to respond to decisionmakers’ information needs regarding the introduction, coverage, use or disinvestment of health technologies. Information needs of decision makers often arise […]
EMA and EUnetHTA finalise joint work plan for 2017-2020
Medicines regulator and network of Health Technology Assessment (HTA) bodies continue to strengthen their collaboration The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have published a joint work plan outlining key areas of collaboration for the next three years. The EMA-EUnetHTA collaboration, which began in 2010, aims to harness […]
WP4 PTJA01 on “Midostaurin (Rydapt©) with standard chemotherapy in FLT3 positive Acute Myeloid Leukaemia” is now available.
Final assessment report on Midostaurin (Rydapt©) We are pleased to announce that the pharmaceutical Joint Rapid Assessment on “Midostaurin (Rydapt©) with standard chemotherapy in FLT3 positive Acute Myeloid Leukaemia” is now available. The final assessment report was published in November 2017. Find the documentation provided by the authoring team here.
Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk
Final project plan for Other Technologies TAVI This is the final project plan of the Other Technologies CA on Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk. Project Plan
WP4 PTJA02 on “Regorafenib (Stivarga©) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib” is now available
Final Assessment Report, External Comments/Answers and Project Plan for pharma JA on Regorafenib (Stivarga©) We are pleased to announce that the pharmaceutical Joint Rapid Assessment on “Regorafenib (Stivarga©) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib” is now available. The final assessment report […]
Alectinib (Alecensa©) as monotherapy for the first line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC)
Final project plan for pharma JA Alectinib (Alecensa©) This is the final project plan of the pharma JA on Alectinib (Alecensa©) as monotherapy for the first line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC). Project Plan
Winter School in Clinical Epidemiology
Winter School in Clinical Epidemiology UMIT – University for Health Sciences, Medical Informatics and Technology, under the Department of Public Health, Health Services Research and Health Technology Assessment, runs a HTADS (HTA and Decision Science) program that comprise 4 modules/courses. Early booking by October 31: savings of over 25% www.umit.at/htads flyer_wsepidemiology2018_htads
