Driving Creative Economy by Strengthening Biopharmaceuticals' Global Capabilities

□ The Minister (Kim, Seung-hee) of the MFDS announced that the "2015 Global Bio Conference" with an aim to advance to the global market by domestically-manufactured biopharmaceuticals, and support the domestic development advanced biopharmaceuticls. The forum will be held from June 29th to July 3rd at Songdo Convensia, Incheon.

○ The conference was designed to help the relevant industry take the lead in the global biopharmaceutical market to enter the league of top 7 bio powerhouse in 2018 as biopharmaceuticals are a new economic growth engine. The meeting is expected to lay the foundation to enhance global competitiveness of the relevant industries during the critical bio golden time of 2015 and 2017.
- Entitled "The Future of Biopharmaceuticals Driving Creative Economy," the conference will be a venue to share international trends and latest regulatory issues of R&D and policies to aid global growth of domestically-manufactured biopharmaceuticals including vaccines and cell therapies.

○ Attendees including about 50 regulatory experts from abroad and 2,000 or so experts from the government, pharmaceutical industry and academia will share and discuss the future and visions of biopharmaceuticals and country-specific policy directives.

□ Main topics for discussion of the conference include global trends, recombinant products' latest development trends, advanced therapies' regulations and development trends, GMP experts seminar, human tissue safety control workshop and regulatory workshop with vaccine and biopharmaceuticals regulators attending.

□ During the conference, another international meeting in biopharmaceuticals will be held.
○ AHC Biopharmaceuticals Workshop designed to develop expert training programs aiming to realize regulatory harmonization in biopharmaceuticals among Asian nations will be held on July 1.
※ Asia-Pacific Economic Cooperation Harmonization Center, AHC: An international organization established in 2009 in MFDS to help authorize medicinal products, medical devices as well as implement harmonized safety control mechanisms.

○ The IPRF with Korea as a chair country biosimilar working group meeting will be held on July 3 to discuss regulatory status of member states and areas of joint collaboration at the WHO.
※ International Pharmaceutical Regulators Forum participating countries and regional organizations: EU, U.S.,, Japan, Switzerland, Canada, WHO, Singapore, China, Russia, Taiwan, Brazil, GCC (Middle East), APEC, ASEAN, PANDRH (Americas), SADC (South Africa), EAC (East Africa)
□ In the congratulatory video message, the Prime Minister Hwang, Gyo-ahn said, "The government will plan to foster Korea's biopharmaceutical industry that possesses top-notch biotechnologies in the world to become an industry with newly-found growth engine."

○ In the opening statement, the Minister Kim said, "I hope the conference will expand into one of the world's largest biopharmaceutical get-together and serve an opportunity to lead global biopharmaceuticals, help to put in place necessary rules and regulations to help research, develop, commercialize and advance to the global market with high quality domestically-manufactured biopharmaceuticals by helping to provide technical support.

□ The MFDS stated that the conference will provide a venue to share expertise and knowledge by international experts, thereby strengthen global capabilities to help the relevant industry advance to the global market.
○ In addition, the MFDS explained that enhancing communication and interactions with other regulatory authorities, ways to beef up safety control, address and respond to global issues of biopharmaceuticals, will improve the trust of the domestically-manufactured biopharmaceuticals.