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Hi Korea 2016 Conference Speakers

Shiki Kumiko
GMP Inspector, Pharmaceuticals and Medical Devices Agency(PMDA), Japan
Session 1  - 14:00 - 15:05, Tuesday, August 23
GMP Compliance Inspection by PMDA
GMP Compliance by Inspection is prerequisite for marketing authorization of a pharmaceutical product in Japan. GMP compliance inspection or investigations must be done not only at the time of marketing authorization application but also after marketing authorization is provided, periodical ones must be given to drug manufacturing sites. Since the establishment of PMDA in 2004, PMDA's Office of Manufacturing/Quality and Compliance have conducted GMP compliance inspections to domestic as well as overseas manufacturing sites. Comprehensively PMDA confirmed methods and practices of quality and production control of APIs and drug products and it has contributed to supply of better quality products. My lecture will present on PMDA's inspection approaches, uncompliant GMP inspection cases, and the necessity for cooperation between overseas API manufacturers and MAHs in Japan.

Suzuki Shogo
Technical Officer, Pharmaceuticals and Medical Devices Agency(PMDA), Japan
Session 1  - 15:20 - 16:25, Tuesday, August 23
The Latest Information on Japan Pharmacopeia and Master Files
The 17th Edition of Japanese Pharmacopoeia has been published in March and enforced in April 2016. The English version will be available in September. In the coming lecture I will explain the main revised parts of the 17th edition, such as comprehensive administration of residual solvents and public comments invitation in the PMDA's English version website and trials for disclosure of the column information.

Regarding the latest information on the master files, I will talk about the requirement for attachment materials of the application dossier of generic prescription drugs which shall be in principle in CTD format according to the notification published in March 2016.

Marieke van Dalen
Global Regulatory Specialist, Active Pharmaceutical Ingredients Committee(APIC), Nethelands
Session 2  - 10:10 - 12:20, Wednesday, August 24
The success strategy to enter EU market with some cases of most frequent mistakes for (Korean) pharmaceutical companies with respect to the API's used(an oversight of the regulatory process in the EU and an overview of the API information)
Regulatory approval in Europe can be achieved through several regulatory procedures, both centralized as well as non-centralized. An important part of the regulatory dossier is obviously the CMC section, which contains the information on the API(s) used in the product. Hot topics in Europe with relation to the API's are the GMP status, the supply chain integrity and the choice of the starting materials. The CEP system which was developed in Europe marks a huge step forward in "stand alone" approval of the CMC information, regardless of the application.

Mrs. Marieke van Dalen works for Aspen Oss B.V., a company located in the Netherlands, producing a wide variety of APIs. She is also a Board Member of APIC (Active Pharmaceutical Ingredients Committee), which is the Technical European Industry Association for API producers, based in Brussels.

Maarten Van Baelen
Market Access Director, Medicines for Europe(Former EGA), Belgium
Session 3  - 14:00 - 16:10, Wednesday, August 24
Generic Medicines: Registration and Pricing Policies in Europe
For launching a medicine on the market in Europe, there are 2 important steps to be taken into account: the regulatory approval of the medicine and the establishment of the price of the product.  This presentation will provide you an overview of the possibilities for granting a marketing authorisation and will discuss EU Member States' policies that impact the significant difference between the gross price and the net price of a medicine.

Maarten joined « Medicines for Europe » in 2011 as Medical Affairs Manager with responsibilities in the areas of fighting Falsified Medicines and Pharmacovigilance. In his life before the association, he worked in the pharmaceutical industry providing pharmacovigilance consultancy and in the medical device industry liaising with Key Opinion Leaders. He combined these roles while working weekends in a community pharmacy. Maarten is a pharmacist by education and holds an MBA from "Solvay Brussels School of Economics and Management" and "École des Ponts Business School".

Jimyoung Kim
Reviewer & Scienctific Officer, National Institute of Food and Drug Safety Evaluation(NIFDS)
Session 4  - 10:10 - 11:00, Thursday, August 25
Korea Regulatory Harmonization of Bioequivalence Study
(1) Recommendation of Bioequivalence study in Korea
(2) CTD form (3)
Regulatory Harmonization of Bioequivalence study .

Yang Seongjun
Deputy Director, Nation Institute of Food and Drug Safety Evaluation (NIFDSS)
Session 4  - 10:10 - 11:00, Thursday, August 25
Current status and Prospect of KP(Korean Pharmacopeia)
The Korean Pharmacopoeia (KP) is a statute for pharmaceuticals established by the Korean government to contribute to the improvement of public health. It aims to provide safe and efficacious pharmaceuticals of assured quality through adequate management of manufacture, quality and storage of pharmaceuticals used for treatment and prevention of diseases.

The first edition of KP was promulgated and published with 635 monographs on October 10, 1958 by Ministry of Health and Welfare Notification No. 25.

MFDS have revised KP periodically. After 4th edition, the revision period is 5 years.

In July 2011, prior to the tenth edition of KP, the MFDS proposed the "Guidelines for Revising the Korean Pharmacopoeia," prescribing specific rules and instructions for revision in order to facilitate systematic and consistent description of information throughout the revised draft. This Guideline have been used as basic policy and guidelines for the revised draft.

The latest edition of KP was promulgated on December 28, 2014 by the Notification of the minister of the Ministry of Food and Drug Safety.

Brian Mi Ph.D.
President, China & Southeast Asia, IMS Health
Session 5  - 13:00 - 14:00, Thursday, August 25
New Normal: Challenges and Opportunities of China Pharma Market
Brian is responsible for IMS Health operations in Greater China, Singapore, Malaysia, Indonesia, Thailand, the Philippines, Vietnam, Pakistan and Burma.

Since joining IMS Health in 2008, Brian has served in key leadership positions within the organization that include general manager of Greater China and senior principal, IMS Consulting Group.

Prior to joining IMS Health, Brian held management roles of increasing responsibility at Pfizer and Amylin Pharmaceuticals focused on portfolio planning, new product marketing, R&D strategy and business development.

Brian holds a Ph.D. in Pharmaceutical Chemistry from the Ohio State University and an M.B.A. from the University of Chicago.

Young Joo Oh
Professional Consultant, Thomson Reuters
Session 5  - 14:10 - 15:20, Thursday, August 25
Licensing and M&A Deal Trend - Boosting External Innovation with Creative Partnership
Partnership is now getting the most important strategy to drive innovation for business success. According to Thomson Reuters (IP&Science) research, over 60% of late-stage pipeline value is generated externally.
In 2015, we have the busiest year of deal-making worldwide, which indicates the proactive partnership by many types of players in pharmaceutical industry. This partnership has been more emphasized due to the more complicated challenges – patent cliff and payer pricing/regulatory pressure. About 50 Billion USD in pharmaceutical industry revenue has been estimated to come off patent in 2014. Governments and other payers are instituting price control and increasing their use of generics and biosimilars. Even with the recent advance in biomedical technology, the successful drug-development companies need to adopt this new wave of technology though creative partnership. The talk will look at how various players in pharmaceutical industry strive on building strategic partnership to drive the next generation of therapeutics by overcoming current challenges.

Free Seminar Speakers

Thomas Jung, M.S.
Vice President, Business Development, KBI Biopharma, USA
14:00 - 14:45, Tuesday, August 23
Accelerated CMC Approaches for Therapeutic Antibody Development
Accelerating the development and delivery of innovative and biosimilar antibodies to patients enhances quality of care and quality of life.  Shortening development times also helps biotech companies efficiently deploy capital while providing their investors with a faster return on investment.  This presentation outlines specific areas where KBI significantly reduces development timelines to enable faster progression into and through clinical trials for therapeutic antibodies.

Emmanuel PETREQUIN
Head Regional Accounts, Asia Pacific at Bollore Logistics Singapore, Singapore
15:00 - 15:45, Tuesday, August 23
Cold Chain Management for Pharmaceutical, medical device
Bollore logistics, headquartered in Paris FRANCE, is a global leader in Int'l Transport & Logistics. We are operating in 102 countries with 21,000 employees. The company has enriched its expertise to become a tier-one supply chain partner and one of the Top 10 logistics company in the world with its integrated logistics network and knowledge. In line with strong corporate QHSE policy and culture, Bollore Logistics Korea has invested to Healthcare logistics in cooperation with the expertise in HQ and Regional Healthcare Management. Our investment result in CEIV Pharma Certificate & opening KGSP warehouse in Osan.

James Namgoong
Healthcare Business Development Manager, Bollore Logistics Korea
15:00 - 15:45, Tuesday, August 23
Cold Chain Management for Pharmaceutical, medical device
Bollore logistics, headquartered in Paris FRANCE, is a global leader in Int'l Transport & Logistics. We are operating in 102 countries with 21,000 employees. The company has enriched its expertise to become a tier-one supply chain partner and one of the Top 10 logistics company in the world with its integrated logistics network and knowledge. In line with strong corporate QHSE policy and culture, Bollore Logistics Korea has invested to Healthcare logistics in cooperation with the expertise in HQ and Regional Healthcare Management. Our investment result in CEIV Pharma Certificate & opening KGSP warehouse in Osan.

Junichi Makino
Health Industry News, Japan
10:15 - 12:00, Wednesday, August 24
- New regulation for health food claims in Japan
- Funtional and health ingredients market in Japan
Japan's New Regulations for Health Food Claims – an Explanation

In April 2015, the Consumer Affairs Agency of the Japanese government implemented new rules for the labeling of health foods. The new kinosei hyoji shokuhin rules are designed to be a middle road between two existing food labels: tokuho, short for tokutei hokenyo shokuhin, or food with specified health uses, and eiyo kino shokuhin, or foods boasting nutrient functions.

Tokuho was launched in 1991 and allows manufacturers to make health claims on their products if the government judges that there is enough scientific evidence of their benefits and safety. Eiyo kino shokuhin, is a label that manufacturers can use so long as the products contain designated vitamins and minerals. The label can be used without reporting to the authorities.

The new labels are similar to tokuho, in that manufacturers can make specific health claims, but unlike tokuho the government does not review or guarantee the safety and efficacy of the individual products.

Trends and Developments in Japan Health Ingredients Market

Japan is home to the third-largest health food market in the world. The category that has the highest market share is for intestinal regulation products. The second largest category is for products aimed at preventing lifestyle-related diseases, followed by products intended to restore a person's health or strength.

The market is dynamic with a constant flow of new ingredients and products being developed and commercialized. This presentation will highlight some of the recent trends and developments in the market and highlight the opportunities for companies wishing to enter the Japan market.

Kohei Shiba
Asia Pacific Manager, Malvern Japan, Japan
14:00 - 15:45, Wednesday, August 24
Applications of physical analyses, such as viscosity, thermal stability, size distribution, chemical spectroscopy and sub-visible particle (SVP)
Therapeutic protein development requires some physical analyses because a protein has each conformation in various formulations. We will here present some applications of physical analyses, such as viscosity, thermal stability, size distribution, chemical spectroscopy and sub-visible particle (SVP) detection with Malvern products. We also trace them on the development work flow for biopharmaceuticals in order to show total solution.

Audrey Dupuy
Technical Support Manager, Lallemand Health Solutions, France
11:15 - 12:00, Thursday, August 25
Probiotics-STAR: Proprietary enteric coating technology
Lallemand Health Solutions (LHS) is pioneer in probiotics for 80 years through expertise and continuing R&D work  to supply the best Probiotic strains and products. Thanks to STAR® 3-level protection technology, Lallemand Health Solutions ensures the optimal delivery of live probiotics in the gut. STAR® can be applied to any custom blends of Rosell, Lafti and Harmonium strains formulated in capsules, and LHS also possesses strong expertise in the selection, development, production, and formulations (specialized, customized blends for customers) that support human health and well-being.