CRED SMPC 2024

17/09/2024

EMA training slides - topics

• The summary of product characteristics – what is it and what does it contain? • Introduction to the summary-of-product characteristics guideline

Section 4.3 Contraindications

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• Section 4.4 special warnings and precautions for use

• Section 4.5 Interaction with other medicinal products and other forms of interaction • Section 4.6 Fertility, pregnancy and lactation • Section 4.7 Effects on the ability to drive and use machines

• Section 1: Name of medicinal product

• Section 2: Qualitative and quantitative composition

Section 3: Pharmaceutical form

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• Section 4.1 Therapeutic indications

• Section 4.2 Posology and method of administration

Section 4.8 Undesirable effects

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The Organisation for Professionals in Regulatory Affairs

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EMA training slides - topics

Section 4.9 Overdose

• The summary of product characteristics and older people

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• Section 5.1 Pharmacodynamic properties

• Pharmacogenomics information in the summary of product characteristics

• Section 5.2 Pharmacokinetic properties

• Section 5.3 Preclinical safety data

• Generic, hybrid and biosimilar products

• Section 6 Pharmaceutical particulars

• The summary of product characteristics of fixed combination medicinal products

• Sections 7 to 10 related to the marketing authorisation; Sections 11 and 12 related to radiopharmaceuticals

Video: Sections 4.1 and 5.1: Therapeutic indications and pharmacodynamic properties

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• The summary of product characteristics guideline and paediatric aspects

• Video: Section 4.8: Undesirable effects

The Organisation for Professionals in Regulatory Affairs

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