• Program & Speaker
  • Detailed Program

세부 프로그램

  • June 28
  • June 29
  • June 30

June 28, 2017

특별 자문단 포럼│Special Advisory Board Forum

Date & Time 10:00~12:00 Venue Jupiter, 30F
- Closed Meeting

개회식│Opening Ceremony

Date & Time 13:30 ~ 14:00 Venue Harmony, B1
- Opening

[GBC1] 기조강연 & 특별강연│Keynote Speech & Plenary Session

Date & Time 14:00~18:00 Venue Harmony, B1
  • 14:00~14:30 4차 산업혁명의 헬스케어 융합과 규제개혁
    Reform of Regulations for Healthcare Convergence in 4th Industrial Revolution
    이민화 (이사장, 창조경제연구회 / 교수, KAIST)
  • 14:30~15:00치료에서 완치로: 헬스케어 이노베이션의 최종 목표를 향한 끝없는 노력
    From Treatment to Cure: Striving for the Ultimate Goal in Healthcare Innovation
    Dr. Michael Goettler (Global President, Rare Disease for Pfizer's Innovative Health Business)
  • 15:00~15:30강소 바이오 기업 - 한국형 연구개발 모델의 선택은?
    Small and Strong - Winning Models in Korea R&D
    Dr. Axel Baur (Senior Partner, Leader of McKinsey’s Asia Healthcare Practice, Mckinsey)
  • 15:30~16:00인지컴퓨팅 시대의 헬스케어
    Healthcare in the Age of Cognitive Computing
    Dr. Michael S. Weiner (Chief Medical Information Officer, IBM Healthcare)
  • 16:00~16:30Coffe Break
  • 16:30~17:00머신 러닝을 이용한 주요암에 대한 선천적인 유전체 감수성의 예측
    Prediction of Inherited Genomic Susceptibility for Major Cancers by Machine Learning
    김성호 (교수, UC Berkeley, USA)
  • 17:00~17:30유도 만능 줄기세포를 이용한 유전질환 모델링
    Modeling of Human Genetic Diseases Using Induced Pluripotent Stem Cells
    한용만 (교수, 카이스트)
  • 17:30~18:00의생명공학분야에서의 3D 프린팅 기술 적용
    Applications of 3D Printing in Biomedical Engineering
    윤원수 (교수, 한국산업기술대 / 대표이사, (주)티앤알바이오팹)

[GBC11] 세계보건기구 사전적격성평가 워크숍│WHO PQ Workshop

Date & Time 14:00~17:45 Venue Vivace, B1
  • 14:00~14:15PQ(사전적격성평가) 소개
    PQ Overview
    Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 14:15~14:30바이오시밀러 PQ 인증 시범사업
    PQ Pilot Process for Prequalification of Biosimilars
    Dr. Drew Meek (Prequalification Team, World Health Organization (WHO))
  • 14:30~14:45백신 PQ 개요
    Vaccine Prequalification Overview
    Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 14:45~14:55PQ 신청자료 - CTD 양식 적용
    New Dossier Format- CTD to Replace PSF
    Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 14:55~15:15PQ평가 : 품질평가 및 관리 체계 적합성
    The PQ Process: Quality Assessment and Programmatic Suitability for Prequalification
    Dr. Drew Meek (Prequalification Team, World Health Organization (WHO))
  • 15:15~15:30PQ평가 : 실태조사
    The PQ process: Inspection
    Mr. Mustapha Chafai (Prequalification Team, World Health Organization (WHO))
  • 15:30~16:00Coffee Break
  • 16:00~16:30생물학적제제 GMP : 백신 실태조사 사례
    GMP Biologicals :Lessons Learnt from Vaccine Inspections
    Mr. Mustapha Chafai (Prequalification Team, World Health Organization (WHO))
  • 16:30~17:00PQ평가 : 임상평가
    Clinical Assessment
    Mr. Olivier Lapujade (Prequalification Team, World Health Organization (WHO))
  • 17:00~17:15PQ 인증품목 사후관리
    Post-Prequalification Monitoring of Prequalified Vaccines
    Dr. Drew Meek & Mr Olivier Lapujade (Prequalification Team, World Health Organization (WHO))
  • 17:15~17:30PQ 인증품목의 국가별 규제당국 협력
    Collaborative Process for National Registration in Recipient Countries of Prequalified Products
    Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 17:30~17:45토론 및 질의 응답

기자 간담회│Press Conference

Date & Time 16:30 ~ 17:30 Venue Allegro, B1
- Closed Meeting


June 29, 2017

[GBC2] 백신 포럼│Vaccine Forum

Date & Time 09:00~18:00 Venue Harmony I, B1
  • 09:00~10:00백신 개발의 혁신과 도전
    Innovation and Challenges in Vaccine Development
    Dr. Stephen Lockhart (Pfizer)
  • 10:00~11:00백신 개발의 역사, 현재 그리고 미래
    The History, Now and Future of Vaccine Development
    Dr. Rino Rappuoli (GSK)
  • 11:00~11:20Coffee Break
  • 11:20~12:20바이오의약품 규제과학 현황 및 향후 전략
    Current Status and Future of Regulatory Science of Biologics
    Dr. Ian Feavers (NIBSC, UK)
  • 12:20~13:40 Lunch
  • 13:40~14:40지카백신 개발 동향
    Development of Zika Vaccines
    윤인규 (IVI)
  • 14:40~15:40백신 면역반응 향상 및 증강을 위한 새로운 아주번트의 사용
    The Use of Novel Adjuvants to Enhance and Broaden the Immune Response Elicited by Human Vaccines
    Dr. Ralf Wagner (Paul-Ehrlich-Institut, Germany)
  • 15:40~16:00 Coffee Break
  • 16:00~17:00백신 임상시험 평가시 통계적 고려사항: 면역원성을 이용한 백신임상시험에 대한 규제적 관점
    Regulatory Challenges in the Design, Analysis and Interpretation of Immunobridging Vaccine Trials Using Correlates of Protection
    Dr. Catherlin Njue (Health Canada, Canada)
  • 17:00~18:00유례없는 공중보건위기와 이에 대응한 에볼라백신의 개발
    Development of an Ebola Vaccine in the Midst of an Unprecedented Epidemic
    Dr. Jayanthi Wolf (Merck, Sharp & Dohme (MSD)

[GBC3] 유전자재조합의약품 포럼│Recombinant Protein Products Forum

Date & Time 09:30~17:30 Venue Harmony II, B1
  • 09:30~10:10 유전자재조합의약품의 개발 역사, 현황 및 미래
    History, Current Status and Future of Recombinant Protein Products
    Dr. Elwyn Griffiths (Health Canada, UK)
  • 10:10~10:50 바이오시밀러의 현황과 미래
    Current Trends and Future of Biosimilars
    Dr. Jian Wang (Health Canada, Canada)
  • 10:50~11:00 Q&A
  • 11:00~11:20 Coffee Break
  • 11:20~12:00로드맵 기반 정밀의료
    Roadmap Based Approach to Precision Oncology 
    백순명 (연세대학교)
  • 12:00~12:10 Q&A
  • 12:10~13:30 Lunch
  • 13:30~14:10 항체약물복합체(ADC) 원천기술을 통한 차세대 항암제 개발
    Creating Next Generation ADCs with Industry Leading DAR Precision and Plasma Stability
    채제욱 (레고켐바이오사이언스)
  • 14:10~14:50 단백질 공학기술(engineering)을 통한 항체 치료제 개발
    Emerging Strategies for Engineering Monoclonal Antibodies with Improved PK/PD
    Dr. Douglas L. Sheridan (Alexion, USA)
  • 14:50~15:30 CHO 세포배양: 항체 및 Fc 융합단백질의 품질조절
    Modulation of the Quality of mAbs and Fc-fusion Proteins in CHO Cell Culture
    이균민 (KAIST)
  • 15:30~15:40 Q&A
  • 15:40~16:00 Coffee Break
  • 16:00~16:40 항체 치료제 차세대 생산 기술 및 규제 고려 사항
    Continuous Bioprocessing: Technology and Regulatory Challenges and Mitigation Strategies
    Dr. Marc Bisschops (Pall Lifesciences, USA)
  • 16:40~17:20유전자재조합의약품 허가 심사시의 면역원성 고려사항
    Immunogenicity Considerations in Review and Approval of Therapeutic Proteins
    Dr. Klara Tiitso (European Medicines Agency, UK)
  • 17:20~17:30 Q&A

[GBC4] 세포유전자치료제 포럼│Cell & Gene Therapy Products Forum

Date & Time 09:30~17:40 Venue Harmony III, B1
  • 09:30~10:00세포유전자치료제의 개발 현황과 전망
    Present and Future of Cell and Gene Therapy Product Development
    Dr. Maria Cristina Galli (Istituto Superiore di Sanità, Italy)
  • 10:00~10:30일본의 세포유전자치료제 개발 현황
    Current Status of Advance Therapies in Japan
    Prof. Teruhide Yamaguchi (Kanazawa Institute of Technology, Japan)
  • 10:30~10:50 Coffee Break
  • 10:50~11:30CAR-T 임상시험 경험과 규제적 고려사항
    Clinical and Regulatory Considerations for CAR-T Cell Therapies
    Prof. Bambi Grilley (Baylor Collge of Medicine, USA)
  • 11:30~13:00 Lunch
  • 13:00~14:00세포유전자치료의 시작: 제약산업의 새로운 발전
    Initiating Cell and Gene Therapy: New Progress for the Pharmaceutical Industry
    Dr. Joseph Tarnowski (GSK R&D, USA)
  • 14:00~15:00암 키메릭 항원 수용체 T 세포(CAR-T) 치료제 개발 사례 발표 : 임상시험 중심
    Development of Anticancer Therapies Based on Chimeric Antigen Receptor (CAR)-T cells:
    CAR-T Cells in Clinical Trials of Hematologic Malignancies
    Dr. Jae Hong Park (Memorial Sloan Kettering Cancer Center, USA)
  • 15:00~15:40세포유전자치료제의 규제정책 방향 (1):
    CAR-T 치료제 개발 및 규제현황
    Regulatory Policy Directions for Cell and Gene Therapy Products:
    Regulation of CAR-T Cell Therapies from Singapore Perspectives
    Dr. Lee Lee Ong (Health Sciences Authority, Singapore)
  • 15:40~16:00 Coffee Break
  • 16:00~16:40세포유전자치료제의 규제정책 방향 (2)
    Update on Regulatory Aspect of Regenerative Medical Products in Japan
    Dr. Masakazu Hirata (PMDA, Japan)
  • 16:40~17:20세포유전자치료제의 규제정책 방향 (3)- 세포치료제의 발전을 위한 FDA 역할
    FDA's Role in Advancing Development of Cellular Products
    Dr. Diane Maloney (FDA, USA)
  • 17:20~17:40세포유전자치료제의 규제정책 방향 (4)
    Regulatory Policy Directions for Cell and Gene Therapy in Korea  
    정지원 (MFDS)

[GBC5] 혈액제제 포럼│Blood Products Forum

Date & Time 09:00~12:40 Venue Vivace, B1
  • 09:00~09:40수혈의학에서의 신기술 발전 현황 및 미래
    Innovation in Blood Banking and Transfusion Medicine
    김현옥 (연세대의대)
  • 09:40~10:20혈장분획제제의 국제적인 공급현황 및 생산 동향
    Current Status and Production Trends of Plasma Fractionation in the World
    Prof. Thierry Burnouf (Taipei Medical University, Taiwan)
  • 10:20~10:40 Coffee Break
  • 10:40~11:20 신종감염병 대응을 위한 혈액제제 개발 현황
    Development of Plasma Therapies in Relation to Emerging Infectious Diseases
    Dr. Glenn Smith (TGA, Australia)
  • 11:20~12:00혈액 및 혈액제제 안정적 체계 구축(캐나다) (화상 강의)
    Establishment of a Reliable Supply of Blood and Blood Products in Canada (Video Conference)
    Dr. Francisca Agbanyo (Health Canada, Canada)
  • 12:00~12:40국가비상 상황시 원료혈장/혈장분획제제의 안정적 공급 지원 체계 구축
    How to Support the Reliable Supply of Source Plasma/Plasma Derivatives during National Emergencies
    김문정 (서남대의대)

[GBC6] 인체조직 포럼│Human Tissues Forum

Date & Time 13:30~17:50 Venue Vivace, B1
  • 13:30~13:50한국의 인체조직 안전관리 정책
    Human Tissue Safety Control Policies of Korea
    문은희 (MFDS)
  • 13:50~14:30인체조직 기증 지원 및 활성화를 위한 제언사항
    The Development of a National Canadian Tissue System: Perspective and Lessons Learned
    Mr. Ken Lotherington (Canadian Blood Services, Canada)
  • 14:30~15:10인체조직 기증자 선택 및 평가시 고려사항
    Considerations When Screening and Testing Donors of Human Tissue
    Mr. Jason LoVerdi (American Association of Tissue Banks, USA)
  • 15:10~15:30 Coffee Break
  • 15:30~16:10조직은행 시설관리 기준 및 관리 방법(청정도, 유지 방법 등)
    Criteria and Mechanisms of Managing Tissue Bank Establishments
    Mr. Brian Bobka (AlloSource, Inc, USA) & Jennifer Drago (Advanced Quality Resources, a Division of Eye and Tissue Resources, USA)
  • 16:10~16:50미국 조직은행표준관리기준(14판) 주요 개정 내용
    Standards for Tissue Banking, 14th Edition: Overview of Changes
    Mr. Jason LoVerdi (American Association of Tissue Banks, USA)
  • 16:50~17:50패널토의
    Panel Discussion

WHO PQ (1:1Meeting)

Date & Time 09:00~12:20 Venue Business Center, 2F
- Closed Meeting

Blood Products│혈액 제제

Date & Time 14:00~16:00 Venue Business Center, 2F
- Closed Meeting

June 30, 2017

[GBC7] 의약품 제조 및 품질관리기준 포럼│GMP Forum

Date & Time 09:20~11:50 Venue Harmony I, B1
  • 09:20~10:00유럽의 바이오의약품 공정밸리데이션
    Process Validation GMP Guideline for Biopharmaceuticals
    Dr. Richard Parker (MHRA, UK)
  • 10:00-10:40미국 FDA의 품질메트릭스 개요
    FDA’s New Initiative: Quality Metrics - Why, What, How and Issues
    윤성규 (University of Massachusetts Lowell, USA)
  • 10:40~11:10Coffee Break
  • 11:10~11:50QbD 기반 바이오의약품 공정개발 사례
    A Study on the Quality by Design Approach for Biopharmaceutical Process Development
    정경희 (Osong Medical Innovation Foundation/Clinical Drug Manufacturing Center)

[GBC8] 해외 규제 당국자 초청 워크숍│Regulatory Workshop

Date & Time 09:00~12:30 Venue Harmony II, B1
  • 09:00~09:05 사진 촬영
  • 09:05~09:10 인사말씀
    Opening Remarks
    유무영 (MFDS)
  • 09:10~09:30 한국의 바이오의약품 허가제도 및 규제 개선 방향
    Sophistication of Biopharmaceutical Regulations
    김남수 (MFDS)
  • 09:30~09:50 싱가포르의 바이오의약품 규제현황 및 향후 계획
    Regulation of Biopharmaceuticals in Singapore
    Dr. Lee Lee ONG (Health Sciences Authority, Singapore)
  • 09:50~10:10 인도네시아의 바이오의약품 규제현황 및 향후 계획
    Regulation on Biopharmaceuticals and Challenges (Indonesian Perspective)
    Mr. Ramjani Simalango (National Ageny for Drug and Food Control, Indonesia)
  • 10:10~10:30 필리핀의 각국의 바이오의약품 규제현황 및 향후 계획
    Registration of Biopharmaceutical Products in the Philippines
    Ms. Norlene I. Chua (FDA, Phillipines)
  • 10:30~10:50 Coffee Break
  • 10:50~11:10 이라크의 각국의 바이오의약품 규제현황 및 향후 계획
    National Regulatory System in Iraq
    Dr. Mohammed Ismael Majeed (Vaccine and Serum Institute, Iraq)
  • 11:10~11:30 사우디 아라비아의 바이오의약품 규제 현황 및 향후 계획
    SFDA Experience on the Regulation of Biopharmaceutical Products
    Dr. Ali Mohammed Al-Samil (SFDA, Saudi Arabia)
  • 11:30~11:50 페루의 각국의 바이오의약품 규제현황 및 향후 계획
    Regulation of Biological Products in PERU
    Ms. Vicky Roxana Flores Valenzuela (DIGEMID, Peru)
  • 11:50~12:10 브라질의 바이오의약품 규제현황 및 향후 계획
    Advanced Therapy Products in Brazil: Where We Are
    Ms. Renata Miranda Parca ( ANVISA, Brazil)
  • 12:10~12:30칠레의 바이오의약품 규제현황 및 향후 계획
    Regulatory Framework for Biological and Biotechnological Products
    Mr. Pablo Diaz Molina (Public Health Institute of Chile, Chile)

[GBC9] 글로벌 진출 전략 워크숍│Gap Analysis to Market Biopharmaceuticals Overseas

Date & Time 14:00~17:30 Venue Harmony II, B1
  • 14:00~14:30독일과 말레이시아 사례비교를 통한 위탁생산 방식 분석
    Contract Manufacturing - An Experience from Germany and Malaysia - Case Study
    Dr. Joachim Walter (Walter Biotech Consultancy, Germany)
  • 14:30~15:00한국 백신회사들의 품질관리체계의 비교 분석
    Gap Analysis in Quality Systems in Vaccine Industries in Korea
    Dr. TED YI (Janssen Korea, Johnson and Johnson)
  • 15:00~15:30 Coffee Break
  • 15:30~16:00바이오시밀러 개발 및 제품화 과정에서 발생하는 과학 및 규제 부분 과제 검토
    Scientific and Regulatory Challenges in Development and Commercialization of Biosimilars
    Dr. Anurag S. Rathore (Indian Institute of Technology Delhi, India)
  • 16:00~16:30바이오의약품 제조분야의 아시아와 유럽 간의 소프트웨어적 차이 분석
    Soft Factors Comparison of Biomanufacturing Between Asia and Europe
    Dr. Bjorn Hammarberg (ABD Life Sciences Ltd, Hong Kong)
  • 16:30~17:30 패널 토의

[GBC10] 임상통계 포럼│Biostatistics Forum

Date & Time 09:30~18:00 Venue Harmony III, B1
  • 09:30~10:00 임상시험계획 및 의약품 허가시 임상통계 심사 : 한국
    Biostatistical Review of IND and NDA in Korea
    남주선 (MFDS)
  • 10:00~10:30 임상시험계획 및 의약품 허가시 임상통계 심사 : 캐나다
    Statistical Review of Clinical Trials: A Regulatory Perspective
    Dr. Catherlin Njue (Health Canada, Canada)
  • 10:30~11:00 신약개발에 있어 통계적 리더십
    Leading Statistical Strategy and Innovation in Drug Development
    김한주 (유한양행)
  • 11:00~11:30 의약품 허가시 규제기관의 통계적 관점
    Statistical Aspects in Regulatory Affairs
    이상준 (셀트리온)
  • 11:30~13:00 Lunch
  • 13:00~13:40 비열등성 임상시험디자인 설계시 고려사항 : 규제기관과 제약회사의 관점에서
    Usage of Noninferiority Design : Points to Consider from Regulatory Agency and Pharmaceutical Companies
    강승호 (연세대학교)
  • 13:40~14:20 Adaptive Design 사용시 고려사항 : 규제기관과 제약회사의 관점에서
    Usage of Adaptive Design : Points to Consider from Regulatory Agency and Pharmaceutical Companies
    최석태 (Celgene Corporation, USA)
  • 14:20~15:00의약품개발시 효과적인 용량결정방법
    Adaptive Dose Finding : An Efficient Way Forward to Improve Drug Development
    Dr. Jiawei Wei (Novatis China, China)
  • 15:00~15:40 백신 안전성 모니터링, 보고, 분석
    Vaccine Safety Monitoring, Reporting and Analysis
    전연 (IVI)
  • 15:40~16:00 Coffee Break
  • 16:00~16:40의약품개발에 있어 real world data 활용
    Use of Real World Evidence in Drug Development
    Dr. Jeff Lange (Amgen, USA)
  • 16:40~17:20건강보험청구자료를 활용한 의약품 부작용 모니터링
    Drug Safety Monitoring using the National Health Insurance Claims Database
    최남경 (이화여대)
  • 17:20~18:00PMDA에서 의약품 시판후 안전성 평가에 대한 현장 데이터의 활용
    Utilization of Real-World Data on Post Marketing Drug Safety Assessment in PMDA
    Mr. Atsushi Noguchi (PMDA, Japan)

[GBC12] 화장품 포럼│Cosmetics Forum

Date & Time 14:00~17:50 Venue Harmony I
  • 14:00~14:10인사말씀
    Opening Remarks
    이동희 (MFDS)
  • 14:10~14:30한국의 화장품 법령·제도 개정사항
    The Forth Industrial Revolution and the Future of Cosmetics
    권오상 (MFDS)
  • 14:30~14:50한국의 최신 화장품 개발동향
    Latest Cosmetics Development Trends of Korea
    박수남 (서울과기대)
  • 14:50~15:30위해성 평가에 근거한 화장품 안전성 평가
    A Risk Assessment-Based Approach to Safety Evaluation of Cosmetic Products
    Dr. Seok (Soga) Kwon (P&G Singapore, Singapore)
  • 15:30~15:45 Coffee Break
  • 15:45~16:20 메이크업 쇼
    Make-up show
  • 16:20~17:00유럽의 최신 화장품 개발동향 및 규제동향
    Latest Cosmetics Development and Regulatory Trends of Europe
    윤여란 (L’Oreal Korea)
  • 17:00-17:40중국의 최신 화장품 개발동향 및 규제동향
    Latest Cosmetics Market and Regulatory Trends of China
    김현정 (MFDS)
  • 17:40~17:50Q&A

바이오시밀러 심사자 워크숍│Biosimilar Reviewer Workshop

Date & Time 09:30~17:00 Venue Vivace I, B1
- Closed Meeting

해외규제당국자 일대일 미팅│Regulatory Meeting

Date & Time 15:00~17:30 Venue Allegro, B1
- Special Event

WHO PQ (1:1Meeting)

Date & Time 09:00~12:20 Venue Business Center, 2F
- Closed Meeting

MFDS-WHO Meeting

Date & Time 14:00~16:00 Venue Mercury, 30F
- Closed Meeting


Date & Time 09:00~12:00 Venue Vivace II, B1
- Closed Meeting

세포유전자 치료제│Cell & Gene Therapy Products

Date & Time 09:00~12:30 Venue Apollo, 30F
- Closed Meeting

인체조직│Human Tissues

Date & Time 09:30~12:00 Venue Mercury, 30F
- Closed Meeting