Module 3 2019

Scientific Advice

EMA

• Advice given by Committee for Medicinal Products for Human Use (CHMP) on the recommendation of the Scientific Advice Working Party (SAWP) • Advice is applicable throughout the EU • Requesting EMA advice does not preclude consultation with national authorities • May/may not involve a discussion meeting (with SAWP)

National (UK)

• Advice given by relevant team via a face-to-face meeting and in writing after the meeting

The Organisation for Professionals in Regulatory Affairs

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