CRED 8 Presentations

01/07/2024

Main tasks of the CHMP • Conducting initial assessment of EU-wide MAAs • Assessing modifications ( variations ) to an existing EU-MA • Deliver opinions to European Commission:  - on new medicinal products/variations/renewals/line extensions - on arbitration/referral procedures • Providing scientific advice and protocol assistance to companies

• Preparing scientific guidelines & regulatory guidance • Establish Working Parties, SAGs & Expert Groups • Interaction with regulators (e.g. ICH process) • Deliver Scientific opinions to WHO

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The Organisation for Professionals in Regulatory Affairs

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Main tasks of the PRAC  Responsible for all aspects of the risk management of medicines • Detection, assessment, minimisation & communication on risk related to medicinal products • PSURs and signal assessment (for CAPs and NAPs) • Design and evaluation of post-authorisation safety studies • Assessments of Urgent/ non-Urgent Union Procedure triggered due to safety concerns (safety referral procedures) • Regulatory oversight of RMP and assessment of outcome of risk minimisation measures in RMP for CAPs (for NAPs only in case of MS request for PRAC advice) • Advice to CHMP on selected post-authorisation procedures

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The Organisation for Professionals in Regulatory Affairs

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