Badeend schreef op 1 juli 2019 14:27:
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Situations for considering the need for a SAG meeting
?Expected major public health interest where public controversy might be expected (e.g.: first-in-class medical product for human use; medical product for a significant new indication).
?Substantial disagreement between rapporteurs and/or CHMP members on issues of clinical judgment and expertise (e.g.: where there is a clearly split CHMP on clinical relevance of beneficial effects or toxicity).
?Controversial issues of such nature that it would be highly beneficial for CHMP to seek the advice as part of the regulatory process (e.g.: high impact on health care professionals, the public and other stakeholders).
?Complex technical aspects, rare disease, need for specialist clinical expertise where CHMP feels it could be beneficial to seek external advice via a SAG (e.g.: novel product or use of new technology; intersection of several scientific disciplines; expertise on scientific techniques or research). ?Questions about risk minimisation measures affecting the clinical practice, where the advice of those currently working in that practice area would be helpful.
?Questions about the design and feasibility of a clinical trial (e.g.: scientific advice, post authorisation commitments) where the requisite expertise is not available within the regulatory system. ?Major post-authorisation safety issues on products such that the risk benefit is questioned.
Dikgedrukt welke twee redenen mij logisch lijken, uiteraard ben ik een simpele belegger en geen expert.