Director, Regional Labeling Head for Asia
How do you make efficient and cost-effective revisions to packaging inserts? How do you design it with the healthcare provider or patient in mind? Moreover, with increased availability of drug information online in the US and Europe, discover how Asia is catching up - with Japan, Korea and Taiwan leading the way in the virtual communication of safety information.
• Designing user-friendly package inserts for healthcare providers and patients to make better-informed decisions
• Mitigating off-label use and identifying risk information for RMPs
• Overcoming challenges faced in revision of packaging inserts across languages and cultures
• Aligning global safety labeling requirements with local package insert policies
• Exploring the benefits and risks of e-labeling
Merger and acquisitions are increasingly on the rise in the pharmaceutical and bio-technology industry. Done out of financial or business reasons, PV is often considered as afterthought and may be addressed late in negotiations on post-conclusions, at the risk of compliance or safety:
• How do you overcome operational challenges and manage the switch in ownership?
• Ensuring safety systems continue uninterrupted and that PV functions are carried out in a timely manner
• The role of the QPPV in ensuring a clear transition of responsibilities and the maintenance of activities
• How is compliance assured across multiple databases?
• Determining that all safety exchange agreements in place and valid