European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting

• Date:
  Tuesday, 17 April 2018
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

During the first day of the meeting digital media and health topics will be discussed, including recent learnings and trends around health, social media, real-word evidence and electronic product information. On the second day, PCWP/HCPWP members will have a chance to hear the latest on EMA relocation, clinical data publication policy and implementation of Clinical Trial Regulation; followed by discussion on findings of the survey on “additional monitoring” awareness. Other topics for discussion include EMA-Heads of Medicines Agencies (HMA) collaboration on shortages and availability of medicines and EMA- European network for health technology assessment (EUnetHTA) collaboration on engagement with patients and healthcare professionals in assessment activities.

Documents

Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting

AdoptedReference Number: EMA/775204/2017

Meeting summary - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting

Reference Number: EMA/259214/2018

List of participants - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting

Reference Number: EMA/56245/2018

Presentation - eHealth at EU level: perspectives from the European Commission - EMA's PCWP and HCPWP joint meeting (Katja Neubauer)

Presentation - Real world evidence (RWE) – an introduction; how is it relevant for the medicines regulatory system? - EMA's PCWP and HCPWP joint meeting (Hans-Georg Eichler)

Presentation - Enhancing evidence generation across the product life cycle: learnings from a series of workshops - EMA's PCWP and HCPWP joint meeting (Alison Cave)

Presentation - Regulatory Perspective on Real World Evidence (RWE) in scientific advice - EMA's PCWP and HCPWP joint meeting (Jane Moseley)

Presentation - Real World Evidence (RWE) – what have we learned recently at EMA? - EMA's PCWP and HCPWP joint meeting (Kieran Breen, Jamie Wilkinson, Courtney Coleman, Isabel Proano, Sofia Marcha, Birgit Bauer)

Presentation - Towards electronic product information in the EU - EMA action plan related to the European Commission’s recommendations on product information - EMA's PCWP and HCPWP joint meeting (A. Skarlatos)

Presentation - Mapping EU initiatives on electronic product information - EMA's PCWP and HCPWP joint meeting (Cà©sar Hernà¡ndez Garcà­a)

Presentation - Digital Media and Health Topic Group - EMA's PCWP and HCPWP joint meeting (Kathi Apostolidis)

Presentation - Innovative medicines initiative (IMI) WEB-RADR project - EMA's PCWP and HCPWP joint meeting (Cà©sar Hernà¡ndez Garcà­a)

Presentation - EMA experience on mHealth technology - EMA's PCWP and HCPWP joint meeting (Francesca Cerreta)

Presentation - Trends in marketing authorisation applications - EMA's PCWP and HCPWP joint meeting (Alexios M. Skarlatos)

Presentation - European Medicines Agency (EMA) on social media- EMA's PCWP and HCPWP joint meeting (Monika Benstetter)

Presentation - Digital Media and Health Topic Group- EMA's PCWP and HCPWP joint meeting (Caroline Morton-Gallagher)

Presentation - Supporting the European Immunization Week - EMA's PCWP and HCPWP joint meeting (Camelia Enachioiu)

Presentation - EMA Technical Anonymisation Group (TAG) - EMA's PCWP and HCPWP joint meeting (Monica Dias)

Presentation - EMA Clinical Data Publication (CDP) - EMA's PCWP and HCPWP joint meeting (Karen Quigley)

Presentation - Implementation of Clinical Trial Regulation – Update on EU-CT portal and database - EMA's PCWP and HCPWP joint meeting (Laura Pioppo)

Presentation - Relaunch of EMA corporate website- EMA's PCWP and HCPWP joint meeting (Angela-Christina Schmidt)

Presentation - European Medicines Agency (EMA)-Heads of Medicines Agency (HMA) collaboration on shortages and availability of medicines - EMA's PCWP and HCPWP joint meeting (Rosa Gonzalez-Quevedo, Annette Byrholt Hansen,...

Presentation - Patient, consumer and health care provider involvement in EUnetHTA JA3 - EMA's PCWP and HCPWP joint meeting (Rosa Anne Willemsen,Chantal Guilhaume)

Presentation - Committee for Orphan Medicinal Products (COMP) feedback - EMA's PCWP and HCPWP joint meeting (Lesley Greene, Daniel O’Connor)

Presentation - Committee for Advanced Therapies (CAT) feedback: Chimeric antigen receptor (CAR) T cell therapies - EMA's PCWP and HCPWP joint meeting (Kieran Breen)

Presentation - Pharmacovigilance Risk Assessment Committee (PRAC) feedback - EMA's PCWP and HCPWP joint meeting (R. Anderson)

Presentation - Healthcare Professionals’ Organisations (HCPWP) feedback from CHMP - EMA's PCWP and HCPWP joint meeting (Fà¡tima Ventura)

Presentation - Young people involvement in the work of the Paediatric Committee (PDCO) - EMA's PCWP and HCPWP joint meeting (Viviana Giannuzzi)

Presentation - European Multiple Sclerosis Platform (EMSP) - EMA's PCWP and HCPWP joint meeting (Andreea Antonovici)