20 – 21 September 2016
Marina Bay Sands, Singapore, Singapore

Rie Matsui

Director, Regional Labeling Head for Asia

16:00 Safety Labeling in Asia: Communicating Risks Effectively

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

16:15 Mergers and Acquisition of PV Functions: How Do You Ensure Compliance is not Compromised?

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

Check out the incredible speaker line-up to see who will be joining Rie.

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