Module 6

04/10/2024

SUMMARY

➢ The SmPC is the key source document for communication on how to use the medicinal product safely and effectively

➢ Working with a variety of stakeholders (internal and external) when designing the SmPC and PIL is vital in providing the best outcomes for patients, healthcare professionals and the company ➢ Comprehensive and clear information equips healthcare professionals with the necessary knowledge to make informed treatment decisions, ultimately enhancing patient care and safety

➢ Accessible information empowers patients to take an active role in their healthcare decisions

You should now have a better understanding of how regulatory can contribute to the above

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Re-cap of learning objectives

An understanding of the importance of the SmPC as a means of communication with prescribers and as the basis for advertising and patient information

1. Importance of the product information and the data contained in the SmPC and its use in communications with patients and prescribers. 2. Patient Information 3. Use and importance of educational materials and public assessment reports for patients and prescribers 4. The role played by patient organisations

5. Importance of advocacy meetings and key opinion leaders

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