NEWS – New Free Educational Regulatory Webinar

This new webinar aims for our regulatory experts to present and provide our listeners with a good understanding of the regulatory framework for compassionate use. Our webinar will guide you through a few examples of requirements, varying across different countries and regions. You will dive into the principles for adverse events reporting in compassionate use and how the requirement differs (or not) from those in clinical trials.

Choose between one of 3 sessions available for this webinar:

• Session 1: 22 September, 6am EST / 11am GMT / 12pm CET
• Session 2: 22 September, 10am EST / 3pm GMT / 4pm CET
• Session 3: 22 September, 2pm EST / 7pm GMT / 8pm CET

Who should attend:

• Pharma/Biotech Industry Regulatory Team
• Regulatory Intelligence Team
• Clinical Regulatory Team Members
• Pharmacovigilance Regulatory Team Members

Key learnings include:

• Introduction to the regulatory framework for compassionate use
• Regulators’ approach to the provision of unlicensed medicines for unmet medical needs: legal definitions and conditions
• Differences between named patient basis and cohort/group approach
• The divergent regulatory landscape in EEA and US
• Regulatory challenges in the implementation of Compassionate Use Programmes (CUP)

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our expert speakers:

Marcelina Rybianska

Ergomed, Regulatory Affairs Associate Director, Strategy

Marcelina has 15 years of experience in global regulatory affairs, supporting Sponsor companies in the execution of successful regulatory strategies for their clinical research programs. She provides Ergomed clients with regulatory solutions and consultancy services across a variety of projects and therapeutic indications.

Tatjana Kosec, MSc

PrimeVigilance, Associate PV Manager, PV Regulatory Intelligence

 

Tatjana is a pharmacovigilance regulatory intelligence expert with extensive knowledge of safety reporting requirements associated with medicinal products in clinical trials, authorised for marketing or made available through special access programmes. She joined PrimeVigilance in 2018 with more than 10 years of working experience in executive government institutions and became involved in continuous development of corporate proprietary intelligence system which now covers 150 countries.

If you have any questions  about our webinar please feel free to contact us