Module 6

02/10/2024

Thank you for listening Questions?

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

65

Additional Reading

Battling maturity in the Pharma product lifecycle: http://www.ttmassociates.com/wp-content/uploads/Battling_Maturity_in_the_Pharma.pdf

Stretching Product Value through Reformulation Strategies: http://www.pharmtech.com/stretching-product-value-through-reformulation-strategies-0 Post-orphan medicinal product designation procedures: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/ WC500196994.pdf EMA annual report on deferrals: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000108.jsp&mi d=WC0b01ac0580925c41 Report from EC – 10 years of the paediatric regulation: https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf Data exclusivity, market protection and paediatric rewards: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

66

33