Session 1

Title The latest trend of Drug MF System & Comparison between MF System in Korea and in Japan
Date 2019. 08. 21 (10:15 - 11:50)
Organization PMDA (Pharmaceuticals and Medical Devices Agency)
Speaker Hirotoshi Sato, Group Technical Expert, Division of Pharmacopoeia and Standards for Drugs Master File Management
Speaker & Lecture Information
2019.4 - Present
1992.1 - Asahi Kasei Corporation (Asahi Kasei Pharma Corporation) Manufacturing manager, QA manager at API Plant, Regulatory Affairs
1982.4 - Toyo Jozo
Bachelor of Science: Chemistry Department, College of Science, Rikkyo University

The Drug Master File (MF) system allows Japanese or foreign manufacturers of drug substances to register at the discretion of the holder the data on quality and manufacturing methods of their drug substances at the PMDA.
In this lecture, we will introduce the points to consider when foreign manufacturers intend to apply MF registration to PMDA. The difference between Japanese MF and Korean DMF will also be mentioned.

Session 2

Title Introduction to the EDQM and the CEP procedure
Date 2019. 08. 21 (13:30 - 15:05)
Organization EDQM – Council of Europe
Speaker Hélène BRUGUERA, Head of the Certification of Substances Department
Speaker & Lecture Information
Mrs Hélène Bruguera graduated in Biochemistry from the University of Nancy, France and has a Master in Industrial Pharmacy from the University of Strasbourg, France. After having worked for the pharmaceutical industry for 10 years, she joined the EDQM in 2000. She is currently the Head of the Certification Department, and deals with the management of CEP applications as well as the EDQM inspection programme for API manufacturers. She is also involved in international platforms related to the quality of medicines and APIs (ICH, IPRP).

The first presentation will give an overview of the activities of the European Directorate for the Quality of Medicines and HealthCare (EDQM), as well as of the procedure for Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). The CEP procedure provides a centralised assessment of the quality of pharmaceutical substances and is increasingly accepted by regulatory agencies worldwide. It is explained how the dossiers are assessed and how the lifecycle of a CEP application is managed. The second presentation is about the EDQM inspection programme for API manufacturers having asked for a CEP, and principles for the use of CEPs.


Title Challenges and opportunities in the Health sector and pharmaceutical market in Chile
Date 2019. 08. 21 (15:30 - 16:20)
Organization Chile PROLMED
Speaker Jean-Jacques Duhart, Executive Vice-President
Speaker & Lecture Information
We will analyze the recent evolution and future trends of the health sector and pharmaceutical market in Chile, and the main challenges and opportunities it presents for international investors and suppliers. Chile currently exhibits one of the most competitive and open economies to international trade and foreign investment in Latin America (ranked 33rd by World Economic Forum), being member of OECD, APEC (host country in 2019) and the Pacific Alliance. Although Chile's health system shows good indicators (life expectancy on the OECD average) and one of the highest growth in health expenditure within OECD, it faces significant challenges (aging population, growing burden of NCDs) and opportunities in order to improve healthcare delivery and expand access to the population to better services and innovative treatments (eHealth, precision medicine, biologics).

Session 4

Title GMP Compliance Inspection by PMDA
Date 2019. 08. 22 (10:15 - 11:50)
Organization C&J (Clarity & Justice)
Speaker Kazuhiko Arai, Representative
Speaker & Lecture Information
Engaged in drug discovery and development research using biotechnology in a chemical company. After that, I was involved in the start-up of a manufacturing plant for developed medicines (sterile preparations) as a production manager and constructed the GMP organizational system and basic concept. In line with the full implementation of the revised Pharmaceutical Affairs Law in 2005, I was involved in the establishment of a generic maker to acquire a new manufacturing and sales business. As General Manager of the Director Trust Assurance Division, I was responsible for the general sales and marketing manager. Currently, as a representative of C& J, I speak, write, and promote GMP consulting activities both in Japan and abroad.

Since Japan joined PIC/S in July 2014, global GMP has been on the rise. Also, this year, the ministerial ordinances on GMP of Japan is scheduled to be revised, and the GMP compliance inspection will also be tightened. In the manufacturing industry, GMP is a licensing requirement, and "GMP compliance" is essential to maintain manufacturing licensing. In addition, in the sales and marketing business, in order to maintain the marketing and marketing approval of the item, you need to confirmed that the production control and quality control of the manufacturing site (including API substance) of the item are appropriate, and "GMP compliance" is obtained. In this seminar, I will explain the points of the GMP compliance inspection by PMDA.

Session 5

Title GMP Certification to enter Thai
Date 2019. 08. 22 (13:30 - 15:05)
Organization Food and Drug Administration (FDA)
Ministry of Public Health, Thailand
Speaker Waranon Cheewajorn, GMP Inspector, Bureau of Drug Control
Speaker & Lecture Information

Session 6

Title Trend and Marketing Strategy for Health Supplyments industry to enter China
Date 2019. 08. 22 (15:30 - 17:00)
Organization China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE)
Speaker Li Guiying Deputy Secretary-general
Speaker & Lecture Information
She is a member of Department of Health & Nutrition of China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), and the Deputy Secretary-general of Dietary Supplement Professional Committee of CCCMHPIE. She is a registered Public Dietitian and graduated from the Institute of Medicinal Plant Development affiliated to Peking Union Medical College of Tsinghua University. Focusing on the policy supervision and laws and regulation research on the medicine and healthcare industry, she is a contributor to many research projects under Ministry of Commerce of China and provides consulting and registration services to Tongrentang and Sinopharm, and helped hundreds of products in the field of dietary supplement, medical devices, and cosmetic from the United States, the United Kingdom, Japan, Korea, and Australia with their access to Chinese market.
Before join CCCMHPIE, She worked in the Dietary Supplement Office of China National Engineering Research Center for the Development of New Chinese Medicine Compound.

This speech will introduce the market conditions, regulatory system managements, access channels and market hot spots of dietary supplements in China. In the speech, the current market characteristics of nutrition and health in China will be analyzed to provide references and suggestions for entrepreneurs to make decisions. And it will systematically and comprehensively introduce the regulations and entry ways of foreign nutrition and health products into China. The speech will also contain the summary and introduction of the current hot products along with product development trend in China.

Session 7

강연 주제 의약품 QbD 제도 추진현황
강의 일정 2019. 08. 22 (10:20 - 10:35)
기관명 식품의약품안전처(MFDS)
연사명 김은경 연구관, 의약품품질과
Speaker & Lecture Information
(경력) 1998년 식품의약품안전처(구 식품의약품안전청)에 입사하였고, 의약품 품질자료 심사, 관련 규정 및 가이드라인 제개정, 대한민국약전 제개정 등을 수행하였음. 2019년부터 현재까지는 식품의약품안전처 의약품품질과에서 GMP 제도 운영 및 실태조사, QbD 관련 사업 등을 담당하고 있음
(학력) 영남대학교 약학대학 졸업 및 동대학 대학원에서 석사 및 박사학위 취득

4차 산업혁명 시대의 제약혁신 성장을 위해 스마트공장을 통한 생산효율성 극대화 및 고도의 품질 확보가 필요함. 의약품 설계기반 품질고도화(QbD)는 스마트공장 구축을 위한 핵심기술로, 국제적으로 의약품 개발 및 제조품질관리에 QbD를 적용하고, 허가신청자료로 요구되는 추세임. 식약처는 의약품 품질혁신을 통한 국민보건 향상과 의약품 국제경쟁력 확보를 위하여 산관학 협력을 통해 QbD 도입기반을 구축하고 있음. 제형별 QbD 예시모델 개발과 기초기술 연구를 추진하고, 관련 규정과 가이드라인을 제개정하여 규제환경을 정비하며, 민관 협의체를 통한 소통과 협력으로 QbD 도입을 추진하고 있음. 본 발표에서는 추진경과 및 주요성과를 소개하고, 향후계획 등을 공유하고자 함.

강연 주제 실험실규모 QbD 정제 예시모델 설계
강의 일정 2019. 08. 22 (10:35 - 11:05)
기관명 부산대학교
연사명 김민수 교수
Speaker & Lecture Information
김민수 교수는 혁신기술 및 QbD 기반의 개량신약 및 신약개발을 위한 preformulation/formulation/dosage form에 관한 연구를 지속적으로 수행하여 90여 편의 SCI 논문을 발표하였다.

본 강연은 QbD 개념 및 원리를 적용하여 의약품의 품질 목표를 미리 설정하고, 제품 및 공정에 대한 이해와 공정 관리를 통한 품질관리를 근거로 하여, 일반방출 정제를 체계적이고 구체적으로 개발하는 내용을 담고 있다.

강연 주제 시생산규모 QbD 정제 예시모델 개발사례 개요
강의 일정 2019. 08. 22 (11:15 - 11:45)
기관명 대구경북첨단의료산업진흥재단
연사명 이해우 팀장, 의약생산센터 / 책임연구원
Speaker & Lecture Information
- 포항공과대학교 화학공학과 박사
- 포항공과대학교 화학공학과 석사
- 포항공과대학교 화학공학과 학사

- 대구경북첨단의료산업진흥재단, 의약생산센터, 고형제생산팀장/제제개발팀장
- University of Massachusetts, 화학공학과, 박사후연구원
- 포항공과대학교, 박사후연구원

- 합성의약품 신약 제제연구/공정개발/스케일업
- 합성의약품 신약/개량신약의 임상시료(IP) 제조

QbD 기반 의약품 개발 사례 –K 정제 (시생산 규모) Example of QbD-based Pharmaceutical Development – K Tablets (Pilot-scale)

강연 주제 정제 실시간 품질관리 및 연속 공정
강의 일정 2019. 08. 22 (11:45 - 12:15)
기관명 종근당
연사명 우영아 이사 (고형제 담당임원)
Speaker & Lecture Information
- 동덕여자대학교 약학과 (학사, 박사)
- 서울대학교 약학과 (석사)
- 미국 오레곤주립대학교 화학과 연구원
- 일본 국립총합연구소 연구원
- 종근당 품질경영 이사
- 현재 고형제 담당 이사

정제 실시간 공정분석기술에 대해 정의, 배경과 목적에 대한 설명을 발표하고 정제 제조에서 혼합, 건조, 코팅 공정을 실시간 품질관리 할 수 있는 공정분석기술 기법에 대해 알아본다. 더 나아가 정제 연속 제조 공정과 공정분석기술의 역할에 대해 설명하고자 한다.