The pharmaceutical industry is subject to increasingly complex regulatory requirements, particularly in the post-approval phase. As companies seek to maintain market authorization and ensure product quality and safety, understanding the nuances of post-approval life cycle management is crucial. During this phase, companies must ensure that their products continue to meet regulatory requirements, while also addressing any emerging safety concerns or manufacturing changes. This webinar aims to provide a comprehensive comparison of post-approval requirements in the European Union (EU) and the United States (US). Our expert panel will delve into the regulatory frameworks while handling practical issues faced by the industry and critical actions to be taken for effective life cycle management. The discussion shall also be highlighting key similarities and differences between the two regions.
Topics to be Covered:
- Overview of post-approval changes in the EU and the US
- Comparison of post-approval changes and variations in the EU and the US
- Strategies for ensuring compliance with regulatory requirements in both EU and US by means of case studies
Key Takeaways:
- Understand the regulatory frameworks governing changes in the EU and the US
- Identify key similarities and differences between the EMA and the FDA requirements
- Develop strategies to ensure compliance with regulatory requirements in both regions
- Learn from case studies and real-world examples of successful implementation of post-approval changes
About the Speaker:
Mona Sharma (M Pharm, Pharmaceutics)
VP & Head – Regulatory Affairs
Mona holds a master’s degree in Pharmaceutics (Formulation Development) and has around 21 years of experience in regulatory affairs (US, Canada, EU, UK, Russia, and CIS countries) and regulatory compliance across drug products (solid orals and sterile) and medical devices. Mona has contributed to formulating regulatory strategies, technical reviews and guidance during the development and scale-up stages, regulatory intelligence support, due diligence reviews, and facility compliance good manufacturing practices (GMP) audits. She also has expertise in compilation of regulatory documents and dossiers. She brings in a lot of expertise and regulatory knowledge from her previous organizations such as Sentiss Pharma Pvt Ltd, Ranbaxy Laboratories Limited, Wyeth Pharmaceuticals (USA), Merck (USA), Accumed (USA), and Dr Reddy’s Laboratories.