![]() Register of EMA decisions on senior staff members leaving EMA Name This rule is based on Article 16 of the Staff Regulations and the European Commission rules on outside activities and assignments and occupational activities after leaving the Service, which apply to EMA by analogy.ĮMA's Executive Director or Management Board issues a decision that may impose restrictions on the staff member's intended occupational activity, to mitigate any potential competing interests in future.Īs of December 2020, EMA's decisions regarding senior staff members leaving EMA are publicly available in the register below for a two-year period following their end of employment at EMA. Breach-of-trust procedureĮMA has a breach-of-trust procedure in place, which sets out how it deals with incorrect or incomplete DoIs by scientific experts and committee members:Īll EMA staff members must request permission to engage in an occupational activity within a two-year period of leaving EMA. The policy takes input from stakeholders into account, including input provided at a public workshop on Best expertise vs conflicts of interests: striking the right balance in September 2013. Requirement to declare interests in relation to personal or organisational involvement in the re-purposing of a medicine.Requirement for members and alternates of EMA’s Committee for Advanced Therapies ( CAT) to declare interests in the biotechnology and medical-device sectors.Alignment of the rules on close family members with those for Management Board members.Restricting involvement in the assessment of medicines by those planning to take up a job in the pharmaceutical industry.Previous revisions to the policy have included the following: The revised policy came into effect on 1 January 2023, following adoption by EMA’s Management Board in December 2022. EMA's reinforced role in crisis preparedness.Īccordingly, this policy now applies to members of EMA's Emergency Task Force (ETF) and Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), as well as to the Executive Steering Group on Shortages of Medical devices (MDSSG).EMA’s new responsibilities in the area of medical devices.The current revision of the policy on handling competing interests of scientific experts and committee members brought it in line with: Requirements for committee chairs and members in a lead role such as rapporteurs are stricter than for other committee members. Requirements for members of scientific committees are stricter than for experts participating in advisory bodies and ad-hoc expert groups. there is no cooling-off period if certain types of interest are no longer present, such as financial interests.for the majority of declared interests, a three-year cooling-off period is foreseen, whereby restrictions decrease over time and distinguish between interests that remain current and those within the previous three years.non-involvement with a company or product throughout an expert's mandate will result from them having held an executive or lead role in the development of a medicine during previous employment with a pharmaceutical company.It includes measures to take into account the nature of a declared interest before determining the length of time any restrictions may apply: ![]() ![]() ![]() The policy reflects a balanced approach and aims to effectively restrict involvement of experts with possible competing interests in the Agency's work while maintaining EMA's ability to access the best available expertise. the type of activity that the expert will be undertaking.The Agency requires each expert to provide information on their interests in the pharmaceutical industry and in the medical-device industry in a declaration of interests (DoI).ĮMA screens each DoI and assigns it an interest level, based on whether the expert has any interests, and whether these are direct or indirect.įor more information and to view the DoIs of individual experts, see European experts.ĮMA uses the information provided to determine if an expert's involvement should be restricted or excluded in specific EMA activities, such as the evaluation of a particular medicine. ![]()
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