Comment: The rules of procedure indicate that Line 96 information on how to submit written contributions will be included with the announcement of the public hearing. We recognise that certain specific aspects of the hearing cannot be addressed until a decision has been taken to hold a public hearing. It would, however, be helpful to provide some general guidance on the EMA website to aid with the timely preparation of written contributions (e.g. format, general points to consider), especially given the likely short period between the announcement and the deadline for submissions. Line 99 Comment: Live broadcast/web stream should not be optional unless integral meeting video/audio/minutes are shortly available after the public hearing in order to provide equal opportunity of information to the public. Line 105 Comment: Members of the public will need to understand whether their contribution in person or via telephone will be reimbursed or at their own expense. This should be clarified in this section. Lines 106 Comment: members of the public may not understand the term or understand/have access to Adobe “teleconference” Connect and therefore may need support with this. Proposed change: can make an intervention in “Speakers person or via telephone (e.g. teleconferencing using facilities such as Adobe Connect) where possible and feasible.” Line 114 Proposed change: will receive a confirmation of “Requesters their request in advance at least 2 calendar weeks ahead of the hearing” Lines 115-116 Comment: See comment line 99. Comment: When appropriate, speakers should reference or Lines 123-132 detail the data source as well as the methodology used for the analysis, in compliance with relevant quality standards for
Line 96 Comment: The rules of procedure indicate that information on how to submit written contributions will be included with the announcement of the public hearing. We recognise that certain specific aspects of the hearing cannot be addressed until a decision has been taken to hold a public hearing. It would, however, be helpful to provide some general guidance on the EMA website to aid with the timely preparation of written contributions (e.g. format, general points to consider), especially given the likely short period between the announcement and the deadline for submissions. Line 99 Comment: Live broadcast/web stream should not be optional unless integral meeting video/audio/minutes are shortly available after the public hearing in order to provide equal opportunity of information to the public. Line 105 Comment: Members of the public will need to understand whether their contribution in person or via telephone will be reimbursed or at their own expense. This should be clarified in this section. Lines 106 Comment: members of the public may not understand the term “teleconference” or understand/have access to Adobe Connect and therefore may need support with this. Proposed change: “Speakers can make an intervention in person or via telephone (e.g. teleconferencing using facilities such as Adobe Connect) where possible and feasible.” Line 114 Proposed change: “Requesters will receive a confirmation of their request in advance at least 2 calendar weeks ahead of the hearing” Lines 115-116 Comment: See comment line 99. Lines 123-132 Comment: When appropriate, speakers should reference or detail the data source as well as the methodology used for the analysis, in compliance with relevant quality standards for
efpia_response_draft_rules_of_procedures_prac.docx