Module 15 2022

19/05/2022

Summary of Safety and Clinical Performance (SSCP)

• Key Messages: • SSCP is based on template provided in the Appendix of MDCG 2019-9. • Minimum content. • Objective: Present favourable and unfavourable data. • Information is sourced from CER, IFU and risk management – consistency between documents. • No promotional or inflationary statements. • Simplicity of language – relevant to user. • Abbreviations and acronyms avoided. If used, defined at first use. • Font type and size should allow easy reading. • PDF – searchable and printable.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

15

Language: Healthcare Professional

• Readability: At the level of intended user • All SSCPs have a Healthcare professional section • These highly qualified clinician have clinical/scientific/statistical understanding. • Medical terminology should be consistent.

“The following can be an approach to therapy of patients with suspected myocardial infarction using conventional drugs with or without thrombolytic therapy or coronary angioplasty. Any patient presenting with prolonged chest pain occurring at rest should have an electrocardiogram. If the ECG is abnormal, an evolving myocardial infarction can be suspected. In this setting, oxygen should be administered if the patient is dyspneic, cyanotic, or has rales in the chest, intravenous nitroglycerin should be given, and the patient's response should be assessed.” Conti CR. Conventional drug therapy of patients with acute myocardial infarction. Cardiovasc Clin. 1989;20(1):249-58.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

16

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