CRED Understanding Clinical Development 2024

09/10/2024

Marketing Authorisation Applications; Summary of Clinical safety • Integrated analyses of all safety information • Clinical trials • Grouping of Clinical Trial Data • Phase I trials • Placebo controlled trials • Active comparator trials • Trials without a control group • Any post-marketing experience • Other analyses • Dose, gender, age, special populations (paediatric , pregnancy, renal impairment etc.), overdose, misuse, medication errors etc.

The Organisation for Professionals in Regulatory Affairs

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EU SmPC

Safety sections of SmPC

• Section 4 • 4.3 Contraindications, 4.4 Special warnings, 4.5 Interactions, 4.6 Fertility, pregnancy, 4.7 Driving, 4.8 Undesirable effects 4.9 Overdose Guidance document for SmPC • ec.europa.eu/health/files/eudralex/vol2/c/smpc_guideline_rev2_en.pd f Training presentations by EMA • http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/doc ument_listing/document_listing_000357.jsp&mid=WC0b01ac0580636 1e1

The Organisation for Professionals in Regulatory Affairs

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