OTJA08 Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin

The final project plan of the assessment on “Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems” and the comments provided by the external experts and the manufacturers are now available. OTJA08_Project_Plan_CGM_and_FGM OTJA08_Compiled_comments_answers_PP_external_experts_manufacturers

Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery

Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery This is the final project plan of the assessment on “Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery” and the comments provided by one manufacturer during a fact check of the draft project plan. Project […]

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]

Proposed Regulation on HTA in Europe

Recent publication of the proposed Regulation on HTA in Europe WP1 Lead Partner, in its function as the EUnetHTA Directorate, acknowledges the recent publication of the proposed Regulation on HTA in Europe. The EUnetHTA JA3 Directorate looks forward to constructive dialogue vis-à-vis the proposed Regulation and continues to actively support HTA collaboration in Europe through […]

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 […]