PROGRAMME

PROGRAMMEDOWNLOAD TIME ZONE TABLE

DAY 1Tue 9 November or Wed 10 November*It is based on the local time of Seoul Korea. (UTC+9)

Tue 9 Nov Wed 10 Nov TOPIC
16:00-16:05('5) 23:00-23:05('5) Opening
16:05-16:15('10) 23:05-23:15('10) Opening remarks (MFDS)
16:15-16:25('10) 23:15-23:25('10) Welcoming remarks (PIC/S)
16:25-16:35('10) 23:25-23:35('10) Introduction and announcement
I. Current Status of Distant Assessment Approaches and Relevant Experiences
16:35-16:55('20) 23:35-23:55('20) Presentation 1ICMRA reflection paper on digital transformation of GCP and GMP inspections (regulatory authority)
16:55-17:10('15) 23:55-24:10('15) Presentation 2PIC/S working group on distant assessment
17:10-17:25('15) 24:10-24:25('15) Q & A
17:25-17:40('15) 24:25-24:40('15) Presentation 3Current development of distant assessment (inspection) technologies (industry)
17:40-18:00('20) 24:40-01:00('20) Presentation 4Case studies on distant assessment(inspection) (industry)
18:00-18:15(‘15) 01:00-01:15('15) Panel Discussion
18:15-18:20('05) 01:15-01:20('05) Introduction on how to participate in workshops
18:20-18:35('15) 01:20-01:35('15) Break
18:35-19:05('30) 01:35-02:05('30)

Workshop I:

1. Current status on distant assessment among regulatory authorities 2. Discussion on latest distant assessment technologies
19:05-19:25('20) 02:05-02:25('20) Break
II. Sharing Information on GMP Inspection Results Based On Mutual Reliance
19:25-19:40('15) 02:25-02:40(’15) Presentation 5Introduction and current status of “ICMRA-PIC/S inspection reliance initiative”
19:40-20:00('20) 02:40-03:00(’20) Presentation 6GMP assessment based on mutual reliance/recognition – (1) EU-US Mutual Recognition Agreement
20:00-20:30('30) 03:00-03:30('30) Presentation 7GMP assessment based on mutual reliance – (2)
20:30-20:45('15) 03:30-03:45('15) Panel Discussion
20:45-20:50('5) 03:45-03:50('5) Introduction on how to participate in workshops
20:50-21:00('10) 03:50-04:00('10) Break
21:00-21:30('30) 04:00-04:30('30)

Workshop II:

1. Advantages of sharing information on GMP inspection results between regulatory authorities based on reliance 2. Difficulties and challenges on sharing information on GMP inspection results between regulatory authorities 3. Ways to overcome such challenges

DAY 2Thu, 11 Nov*It is based on the local time of Seoul Korea. (UTC+9)

Thu, 11 Nov TOPIC
III. Summary and Closing
20:00-20:05('5) Introduction
20:05-20:45('40) Summary of workshop
20:45-21:15('30) Q & A
21:15-21:20('5) Wrap up
21:20-21:45('25) Invitation to 2022 PIC/S Annual Seminar and PIC/S 50th Anniversary
21:45-21:55('10) Closing Remarks
21:55-22:00('5) Closing of the Seminar

Mr. Martin ReedMedicines and Healthcare products Regulatory Agency (MHRA)

PositionSenior GLP and GMP Inspector
CountryUnited Kingdom
ProfileMartin has been with the MHRA for 6 years, joining in 2015 as a GLP inspector and subsequently cross training to inspect GMP quality control laboratories. During my time at the agency he has conducted in excess of 150 inspections. Within GMP these inspections have covered Physical/Chemical testing as well as Sterile and non-sterile microbiology. Martin has a Batchelor's degree in Biochemistry from the University of Newcastle. Prior to joining the agency he worked for 7 years in contract research organisations. During these 7 years he fulfilled a variety of roles within GLP compliant facilities as well as extensive experience of clinical trial sample analysis. Martin has interacted with global regulators for a number of years through the OECD GLP working group and has contributed to the development of guidance documents through this group.

Ms. Jenny HantzinikolasTherapeutic Goods Administration (TGA)

PositionDirector of Inspections Section Manufacturing Quality Branch
Country
Profile

TBD

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Profile

Dr. Siegfried SchmittParexel International

PositionVice President Technical
CountryUnited Kingdom
ProfileSiegfried graduated in 1986 with a PhD in Organic Chemistry from the University of Bern, Switzerland. He has previously held positions in industry as Senior Production Chemist with Roche, Global Quality Director with GE Healthcare, Validation Manager with Raytheon and Senior Lead Consultant with ABB. He joined Parexel Consulting in 2007, where he provides consulting services to the healthcare industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems. The services cover the entire product lifecycle, from the clinical to the commercial phase, for all aspects of the Good Practices. Siegfried’s areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products. Specifically, he consults on compliant quality systems that integrate industry best practices with future-looking compliance approaches. Siegfried has performed over 180 audits on four continents. He is an active member of several industry associations, including PDA, ISPE, RAPS, DIA and he is a Fellow of the Royal Society of Chemistry. He is an author and editor of over 25 books and more than 125 articles. He regularly presents at or is a member of the organizing committee for international events. In particular, he has been a contributing author to the PDA Points to Consider in Remote and Hybrid GMP/GDP Inspections document.

Mr. Vincent O'ShaughnessyAmgen Technology (UC), Ireland

PositionExecutive Director Quality, Quality Site Head
CountryIreland
ProfileWith 25 years in the biotechnology and classical pharmaceutical sectors, Vincent O’Shaughnessy is currently the Executive Director of Quality and Quality Site Head for the Amgen Dun Laoghaire (ADL) facility located in Dublin, Ireland with regional responsibilities extending to the Amgen, Breda packaging facility located in the Netherlands. As the Quality Site Head and Site Leadership Team member, Vincent has direct oversight and responsibility for all aspects of Quality Assurance and Quality Control at the Amgen Dun Laoghaire aseptic manufacturing and packaging facility and leads a large team of quality professionals. Vincent joined Amgen in 2012 and has held roles of increasing responsibilities, including Director Quality Assurance and Primary Qualified Person at ADL from 2012 – 2017. Vincent also worked in the Amgen Thousand Oaks facility in the U.S. as a Quality Director from 2017 – 2019, with oversight for both Drug Substance and Drug Product Manufacturing facilities in addition to warehousing, incoming quality assurance and the disposition function. Prior to joining Amgen, amongst other roles including Quality Control and Technical Services, Vincent was involved in in a significant facility start-up team in 2002, which involved the construction and qualification of a 90 acre facility – the Wyeth Biopharma campus at Grange Castle (subsequently acquired by Pfizer in 2011). Vincent held varying positions of increasing responsibility during his 10 years at Wyeth including Site Auditing and Compliance Lead, Qualified Person and was the principal point of contact for regulatory inspections and compliance. Vincent obtained a B.Sc. (Hons) in Pharm. Sciences from the University of Greenwich in 1996 and holds a post-graduate diploma and M.Sc. in Pharm. Technology from Trinity College Dublin (2004 and 2008, respectively).

Ms. Bethany WillisGenentech, Inc.

PositionQA Senior Technical Manager, Global Quality Inspection Management
CountryUnited States
ProfileBethany Willis is a QA Senior Technical Manager at Genentech (A Member of the Roche Group). She is a member of a team collaborating with Roche sites across the globe in systems and processes related to Health Authority inspection management. Throughout her time at Genentech, she has worked in Drug Product Operational Excellence, Quality Control Raw Materials, and Technical Services. She earned a Bachelor of Science in Industrial and Systems Engineering from The Ohio State University.

Mr. Stephen FarrellTherapeutic Goods Administration (TGA)

PositionDirector of GMP Clearance
CountryIreland
ProfileStephen is the Director of the TGA's Inspection Reliance framework known as GMP Clearance and has been with the TGA since 2016. He manages a large team of GMP assessors performing desk-top assessments of overseas manufacturers to support Australian marketing authorisations. Prior to joining the TGA, Stephen spent over 10 years working in GMP environments in both Ireland and Australia. He has experience across a number of manufacturing disciples including medical devices, recombinant drug substance manufacture, terminally sterilized and aseptic manufacturing fill/finish as well as radiopharmaceuticals. Stephen is also the chair of PIC/S Working Group on inspection Reliance.

Mr. Andrei SpineiEuropean Medicines Agency (EMA)

PositionManufacturing Group Coordinator, Inspections Office
CountryRomania
ProfileAndrei Spinei is a Scientific Administrator in the Inspections Office of the European Medicines Agency. He has joined EMA in 2014 and has since taken up different roles within the manufacturin g area, being involved in inspection coordination, market surveillance and international collaborati on on inspection policies. He is now the Manufacturing Group Coordinator of the Inspection Office and is working closely with the EU GMP Inspectors Working Group and PIC/s. Andrei holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked for 7 years in the Pharmaceutical Industry.

Dr. Elizabeth MillerUnited States Food and Drug Administration (US FDA)

PositionAssistant Commissioner for Medical Products and Tobacco Operations
CountryUnited States
ProfileDr. Elizabeth Miller recently rejoined the US FDA in March 2020. In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff. Dr. Miller comes returns from the U.S. Pharmacopeia (USP) where she helped guide USP’s working relationship with the FDA. At USP, Dr. Miller was vice president, US Public Policy & Regulatory Affairs, with responsibility to deliver executive leadership for developing and achieving USP’s US regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change focused on impacts and results resulting from engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances. Before rejoining USP in 2016, Dr. Miller began her federal career with FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC). She began her CDER career working on online pharmacy and health fraud issues, and ultimately served as the director for OUDLC’s Division of Nonprescription Drugs & Health Fraud. Prior to federal service, Dr. Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labelling, and packaging, and as the director of drug information for the USP Drug Information publication. She started her pharmacy career working as a clinical pharmacist at MedStar Washington Hospital Center in Washington D.C. Dr. Miller holds a bachelor’s degree in biology from The Johns Hopkins University and received her Doctor of Pharmacy degree from the University of Maryland

Ms. Yu-Chun LiangTaiwan Food & Drug Administration (TFDA)

PositionSection chief of supervening the GMP compliance of foreign pharmaceutical manufacturers
CountryChinese Taipei
ProfileTo be updated.

Mr. Eric Verdon Health Canada

PositionRegulatory Compliance and Enforcement Officer
CountryCanada
ProfileEric is currently acting as a compliance and enforcement advisor with the foreign paper assessment team within Health Canada. He obtained a bachelor of science from the University of Ottawa in 2017 and began his career with Health Canada in the Health Product Inspection and Licensing branch shortly after in 2018. His first key responsibilities involved screening GMP evidence to facilitate reviews of foreign pharmaceutical companies. Eric was also responsible for assisting inspectors with their reviews of the GMP evidence and assisting stakeholders in meeting Health Canada’s GMP evidence requirements. He has continued working within HPIL since 2018 where he has continued to learn and gain valuable experience. Most recently, Eric has been working on projects with the goal of program and process improvement.

Ms. Sherry Bahaw Health Canada

PositionRegional Regulatory Compliance & Enforcement Officer
CountryCanada
Profile■ CAREER HISTORY & ACCOMPLISHMENTS ●Regional Regulatory Compliance & Enforcement Officer, GMP Inspection Central (2018 to 2021) - Conducted onsite inspections of pharmaceutical companies to ensure the sites are in compliance with the Food and Drug Regulations and Food and Drug Act - Reviewed foreign regulator inspection reports to approve international sites to produce pharmaceutical product for the Canadian market. - Participated in the Virtual Inspection Committee and Project Cipher Committee (Using Artificial Intelligence to improve efficiencies within the inspectorate) ● Policy Analyst – Director General Office, Health Product Compliance Directorate (2020 to 2020) - Initiated proposals for implementation of improved process of monthly performance indicators - Participated in the creation of a Policy Planning Unit manual - Facilitated the creation of the Performance Indicators for the Natural Health Product Program - Contributed to preparation to Health Canada’s Departmental Plan (2021/2022) ● Regional Regulatory Compliance & Enforcement Officer, Cannabis Directorate (2018 to 2018) - Conducted onsite inspection of License Producers to ensure the sites are in compliance with the Cannabis Regulations - Reviewed paper assessments of new License Producers to determine whether the firms had the necessary requirements for license ● TEVA CANADA LIMITED (2003 to 2018) - Project Manager (2012 to 2018) - Commercial Launch Demand Planning Analyst (2005 to 2012) - Project Manager (2003 to 2005) ■ EDUCATION & CREDENTIALS - PMP Certified (2019) - Project Management Institute - Lean Six Sigma, Green Belt (2014) - More Stream University - Masters of Business Administration (MBA) (2001) - Niagara University (ACCSB Accredited)(Strategic Management) - Bachelor of Science (B.Sc.), Microbiology & Human Biology (1995) - University of Toronto

Mr. Stephen FarrellTherapeutic Goods Administration (TGA)

PositionDirector of GMP Clearance
CountryIreland
ProfileStephen is the Director of the TGA's Inspection Reliance framework known as GMP Clearance and has been with the TGA since 2016. He manages a large team of GMP assessors performing desk-top assessments of overseas manufacturers to support Australian marketing authorisations. Prior to joining the TGA, Stephen spent over 10 years working in GMP environments in both Ireland and Australia. He has experience across a number of manufacturing disciples including medical devices, recombinant drug substance manufacture, terminally sterilized and aseptic manufacturing fill/finish as well as radiopharmaceuticals. Stephen is also the chair of PIC/S Working Group on inspection Reliance.

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Position
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PIC/S SEMINAR STREAMING

*It is based on the local time of Seoul Korea. (UTC+9)

16:00

16:00-16:35Your local time 14:00 PM, 9 Nov (UTC+7)

Opening Remarks / Introduction and announcement

16:35

16:35-18:15Your local time 14:00 PM, 9 Nov (UTC+7)

I. Current Status of Distant Assessment Approaches and Relevant Experiences

  • 16:00-16:35ICMRA reflection paper on digital transformation of GCP and GMP inspections (regulatory authority)
  • 16:55-17:10PIC/S working group on distant assessment
  • 17:10-17:25Q & A
  • 17:25-17:40Current development of distant assessment (inspection) technologies (industry)
  • 17:40-18:00Case studies on distant assessment(inspection) (industry)
  • 18:00-18:15Panel Discussion

18:35

18:35-19:05Your local time 19:05 PM, 9 Nov (UTC+7)

Workshop I

ENTER

19:25

19:25-20:45Your local time 14:35 PM, 9 Nov (UTC+7)

II. Sharing Information on GMP Inspection Results Based On Mutual Reliance

  • 19:25-19:40Introduction and current status of “ICMRA-PIC/S inspection reliance initiative”
  • 19:40-20:00Case studies on GMP assessment based on mutual reliance/ recognition – (1) EU-FDA GMP MRA
  • 20:00-20:30Case studies on GMP assessment based on mutual reliance – (2)
  • 20:30-20:45Panel discussion

21:00

21:00-21:30Your local time 19:05 PM, 9 Nov (UTC+7)

Workshop II

ENTER

23:00

23:00-23:35Your local time 14:00 PM, 10 Nov (UTC+7)

Opening Remarks / Introduction and announcement

23:35

23:35-01:15Your local time 14:00 PM, 10 Nov (UTC+7)

I. Current Status of Distant Assessment Approaches and Relevant Experiences

  • 23:35-23:55ICMRA reflection paper on digital transformation of GCP and GMP inspections (regulatory authority)
  • 23:55-24:10PIC/S working group on distant assessment
  • 24:10-24:25Q & A
  • 24:25-24:40Current development of distant assessment (inspection) technologies (industry)
  • 24:40-01:00Case studies on distant assessment(inspection) (industry)
  • 01:00-01:15Panel Discussion

01:35

01:35-02:05Your local time 19:05 PM, 10 Nov (UTC+7)

Workshop I

ENTER

02:25

02:25-03:45Your local time 14:35 PM, 10 Nov (UTC+7)

II. Sharing Information on GMP Inspection Results Based On Mutual Reliance

  • 02:25-02:40Introduction and current status of “ICMRA-PIC/S inspection reliance initiative”
  • 02:40-03:00Case studies on GMP assessment based on mutual reliance/ recognition – (1) EU-FDA GMP MRA
  • 03:00-03:30Case studies on GMP assessment based on mutual reliance – (2)
  • 03:30-03:45Panel discussion

04:00

04:00-04:30Your local time 19:05 PM, 10 Nov (UTC+7)

Workshop II

ENTER

20:00

20:00-22:00Your local time 14:35 PM, 11 Nov (UTC+7)

III. Summary and Closing

  • 20:00-20:05Introduction
  • 20:05-20:45Summary of workshop
  • 20:45-21:15Q & A
  • 21:15-21:20Wrap up
  • 21:20-21:45Invitation to 2022 PIC/S Annual Seminar and PIC/S 50th Anniversary
  • 21:45-21:55Closing Remarks
  • 21:55-22:00Closing of the Seminar