About the Conference
The Trans-Pacific Health Sciences Dialogue is a meeting for C-level biopharmaceutical industry executives and business development executives who want to accelerate, explore and develop collaborations and partnerships with their counterparts in the most important Trans-Pacific health care markets including Japan, China, South Korea and North America.
This is a must-attend meeting for executives who have, or want to develop, a Trans-Pacific strategy. The event has developed a well-earned reputation as the best place for biopharma companies seeking to forge Trans-Pacific ventures to start exploring their options. Attendees come away with a broad overview and insights they simply will not get in other meetings.
Take a look at some photos from the 2014 Trans-Pacific Health Sciences Dialogue!
In 2015, the Trans-Pacific Health Sciences Dialogue will be held at:
Joseph B. Martin Conference Center
at Harvard Medical School
77 Avenue Louis Pasteur
Boston, MA 02115
Who Should Attend
The Trans-Pacific Health Sciences Dialogue is an event for senior biopharmaceutical executives, KOLs, select industry advisors and members of the financial community with a strategic interest in Trans-Pacific collaboration or investment.
Industry News from BioCentury
- FDA issues draft guidance on reporting CMC changesFDA issued draft guidance advising pharmaceutical companies on which changes must be reported to FDA with respect to chemistry, manufacturing and controls information for approved drugs and biologics.
Sponsors must notify FDA, through a supplement or inclusion in an annual report, of any changes to CMC information that meet the definition of an "established condition." These include descriptions of the product, manufacturing process, facilities and equipment, and "elements of the associated control strategy" that assure process performance and quality of an approved product.
The draft, entitled "Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products," is open for comments until July 31.
Industry News from PharmAsia
- ANALYSIS: Should Innovators Be Pursuing Biosimilars?Patent expiries, pricing pressures and the emergence of approval pathways in countries like China and Brazil mean that biosimilars offer a substantial global opportunity. There are many good reasons why originator companies should consider investing in this market segment, say Anna Buscall and Christopher Stothers.<img src="http://feeds.feedburner.com/~r/_PharmAsiaNews/~4/jAHd-5H8DPM" height="1" width="1" alt="" />