EFPIA & POLITICO: The shake-up of orphan and pediatric rules

Datum: 17 March 2022
Tijd: 09:00 - 10:00
Locatie: Online

Questions to be addressed include:

• What can the health care sector expect from the revamped orphan and pediatric rules ?
• Does the definition of rare disease still make sense?
• How can incentives be balanced with the need to create financially sustainable health systems in Europe? And how can incentives stimulate innovation in areas of real unmet needs?
• Do the current incentives match the difficulties companies face when developing orphan drugs?
• How can Europe achieve faster, more equitable access to orphan medicines across the bloc?

As all of these questions are high priority on the current France’s EU Council Presidency agenda, this event will take a critical look at the current model and deep dive into the most salient issues the revamp of pharmaceuticals rules will need to tackle and explore ways to overcome them.

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EFPIA & EFGCP “Good Lay Summary Practice” Recommendations

Datum: 9 November 2021
Tijd: 00:00 - 00:00
Locatie: Webinar

A multistakeholder group consisting of 60+ academic, industry, not-for-profit and patient organisations, jointly led by EFGCP and EFPIA, (“Roadmap Initiative for Good Lay Summary Practice”), compiled needs for transparency improvement on clinical study results, available guidance and experience when preparing and disseminating Lay Summaries (LS) in Europe and the US. Based on existing recommendations for Lay Summary structure and content, recommendations for the planning, development, translation, and dissemination of LS with systematic patient involvement were developed in collaboration with the Commission’s Expert Group on Clinical Trials (CTEG) and published by the EU Commission in EudraLex Volume 10. This free webinar will give you an opportunity to learn about these new European recommendations and provide you with ideas on how and when to be ready to fulfil this new regulatory requirement.

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EFPIA: Are current investments in medical research focusing on unmet health needs?

Datum: 26 March 2021
Tijd: 00:00 - 00:00
Locatie: Online

The EFPIA Pipeline Review has found that in 2020 alone, around 5,000 clinical trials were initiated to investigate and develop new therapies and vaccines. Almost 50% of therapies in development are new substances, with 40% of the pipeline targeting rare diseases, and groundbreaking cell and gene therapies growing in importance. This exciting new wave of medical innovation will play a key role in addressing the challenges faced by patients and healthcare systems. To coincide with the publication of EFPIA’s annual “Pipeline Review”, we are organising a high-level panel discussion around the latest medical research outcomes.

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