Rie MatsuiDirector, Regional Labeling Head for Asia
Rie Matsui is currently Director, Regional Labeling Head for Asia, International Labeling Group, WSO, Worldwide Safety & Regulatory, Pfizer. She has established the Asia Labeling Hub in Pfizer since July 2012 and the Asia Labeling Hub has created the local label updates for more than 20 countries in Asia. She is working with 14 affiliates in Asia.
Previously, she was a Senior Labeling Manager in Regulatory Affairs, Pfizer Japan. She was driven Japan labeling for global pharmaceutical products within Wyeth Japan (now Pfizer) since 1993. She led responses to support post-marketing label changes in Japan arising from both new data and regulatory requests. In addition, she has led the development of Japan submission labels for new global products. She has extensive experience working with PMDA. She is a proponent of proactive collaboration between global teams and local teams in the management of labeling and risk management plans prior to PMDA submissions.
Since 2012 she has been a member of the content committee in DIA Japan and she was the program chair for the DIA Japan labeling workshop in February 2015 and a member of the program committee for the DIA Japan risk management workshop in March 2015 as well. She made presentations at the DIA China annual meeting in 2013 and 2014. Since 2004 she has been a member of the labeling working group of the DIA Regulatory Affairs Special Interest Area Community. She published a paper entitled “US Prescribing Information: New Requirements” in the Pharmaceutical and Medical Device Regulatory Science.
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