New drug development and launches will continue to progress in Asia Pacific and the market is projected to reach USD62.5 billion by 2026. Regulatory priorities will evolve accordingly, and also keep in mind post COVID requirements.
Are timelines, review, and approval process in favour of the manufacturers? The regulatory Affairs role will get more complexed and challenged working in Asian markets that are governed by diverse and rigorous regulatory and safety requirements during and post-COVID periods.
The 14th Annual Pharmaceutical Regulatory Affairs, a digitally delivered conference is a one stop shop for Global and Asian executives. Understand the market complexities, hear compliance solutions from peers, and stay on top of regulatory imperatives for the medium to long term.
- Regulatory Priorities, Flexibility and Developments Post COVID-19
- Successful case studies of eCTD, timeline and scope
- Regulatory risk management on pharmacovigilance – pre and post-marketing
- Regulatory requirements and views on a life-cycle approach to quality and safety of pharmaceutical products
- Generics, biosimilars, OTC, combination therapies and biologics
- Asia OTC Regulatory Strategy Development
- Insights on the supply chain, labelling and packaging
- Regulatory strategy on data protection & privacy in the digitalisation of Pharma
- Comparisons of CMC Variations in the Region & Managing Complications
- Assessing the Impacts of COVID-19 Against Pharma Competition Law