• Developments in pharma regulatory affairs in Asia against a global outlook, and how it will impact future launch environments
• Strategies and best practices for navigating evolving, complex regulatory environments
• Pain points and drivers of launch excellence and ensuring market adaptability, flexibility

• Regulatory Environment of Asia Pacific
• FDA and EMA opinions
• Challenges and opportunity on Botanical Drug Development

• What are the considerations and influences on intellectual property protection with the rise of internationalisation, harmonisation and digitalisation?
• Emerging approaches for IP strategies and its regulatory implications

• Eliminate silos to develop a proactive cross-functionally interacting team leading to integration of functional expertise and business goals
• Practice timely and effective communication for a successful cross-functional integration
• Leverage cross-functional expertise to strengthen relationships with regulatory agencies

• Impacts of ICH E17 and considerations for regulatory decision-making in the evolving landscape of clinical development
• Best practices and industry perspectives on meeting different requirements
• Managing clinical studies and regulatory strategies following E17 implementation

• China’s current regulatory landscape and structure – what’s changed and what else to expect
• IND application procedures and streamlining of clinical trial administration
• Fast-tracking of drug approvals and updated review processes

• Developments in EMA’s GVP guidelines and modules, EudraVigilance monitoring
• GVP practices in Asia, US and best practices for aligning current practices and regulatory strategies

• Challenges in compliance will be discussed
• The importance of QMS and key elements will be reviewed.
• The practical steps in ensuring quality and compliance to ICH GCP E6(R2) and Singapore Human Biomedical Research Act will be discussed

• GMP guidelines in Asia – what to expect, and what are the key differences
• Quality, lifecycle management

• Uptake and progress on drug e-labelling initiatives in EU, US, Japan
• What are the risks, concerns, and key considerations for implementation in Asia and what are its impacts?
• How can regulatory affairs support the adoption of electronic labelling?

• Overview of M&A activity and forecasted areas of growth in pharma
• Emerging pharma business models, broadening value propositions, and sustainable revenue models
• Enabling drivers of innovation for Asian markets
• Pharma outlook for Asian markets & forecast for the future

ICH CTD/eCTD is global regulatory submission standard which has been implemented for many years in majority of developed pharmaceutical markets but was still new to the emerging markets especially for APAC region. With recent regulatory landscape changes, more and more APAC countries are transitioning their policy or guidelines to make full alignment with ICH standards to implement either CTD or eCTD (i.e., Australia, Thailand, Korea, Singapore and China). The IBC Asia will invite Pfizer experts of CTD/eCTD to introduce the regulatory requirements of CTD/eCTD, how to interpret eCTD specification, and share successful cases in eCTD submission/pilot for Thailand/China.

Topics:

• The Structure and Format of CTD/eCTD (30 min)
• Management of eCTD Life Cycle (30 min)
• Overview of eCTD Specifications (30 min)
• Global eCTD Transition and Case Study (30 min)
• China eCTD implementation Update (30 min)
• Panel discussion (30 min)

Quality and uninterrupted access are key objectives in managing post-approval changes. How can regulatory affairs professionals continue to ensure regulatory flexibility and enforcement discretion while managing post-approval activities? This interactive workshop aims to provide participants with a better understanding of how to formulate regulatory strategies with key CMC and lifecycle management considerations in mind.

Key Takeaways:

• Get up to speed on global regulatory updates on Lifecycle Management and GMP Compliance Standards
• Overview of primary causes of drug shortages & global challenges
• Dealing with post-approval changes according to ICH Q12
• Regulatory strategies for managing post-approval changes and uninterrupted access

For workshop leader opportunities, kindly contact Genevieve.Lim@ibcasia.com.sg