10 years of interaction with EMA

15/12/2021 134 Views
10 years of interaction with EMA

UEMO is pleased to be part of the distinguished 38 stakeholders that have bene interacting with the European Medicines Agency (EMA) over the past 10 years.

EMA recognises that healthcare professionals are present in all aspects of medicines regulation as members of committees and expert groups, in addition to the specialists that are invited on specific issues.  The Agency believes that the perspective of the practicing clinician or community/hospital pharmacist or specialist nurse “brings a beneficial viewpoint to the discussions”.

“The ultimate goal is to bring on board organisations that represent different fields of clinical expertise and practitioners in Europe active within the broad spectrum of health care, including primary care”, stated EMA.

In 2004, the revised pharmaceutical legislation (Regulation (EC) No 726/2004) foresaw, for the first time, the inclusion of one representative of doctors’ organisations in the EMA Management Board, leading to the appointment later on in September 2005 of Lisette Tiddens-Engwirda, then SecretaryGeneral of the Standing Committee of European Doctors (CPME), as the first representative.

Steps leading to a framework of interaction

Still in 2004, the EMA initiated the drafting of a policy to involve patient and consumer groups, building upon several years of experience of interaction with these groups. It also released the EMEA Roadmap to 2010 for public consultation.

The final roadmap was then published in March 2005, clearly identifying as a specific action to engage more fully in dialogue with healthcare professional organisations, academia, learned societies and other stakeholders.

In September 2005, the EMA Management Board agreed to first finalise a framework for interaction with patient organisations due to the advanced state of play of preparations, which should then be followed closely by a framework for interaction with the organisations of healthcare professionals.

In 2006, EMA organised a first workshop1 with healthcare professional organisations which led to the creation of an informal group. This group, co-chaired by Noel Wathion and Isabelle Moulon, ran for several years, as the precursor of what would become EMA Healthcare Professionals’ Working Party (HCPWP), and was instrumental in developing the EMA interaction with healthcare professional organisations.

In 2011, a first formal framework of interaction with healthcare professionals was adopted by the EMA Management Board.

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