4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements

Workshop Materials

• Workshop Program (FINAL)
• Workshop Speaker Bios

Presentations

Day 1 – Monday, November 9, 2020

Session 1

• • Welcome and Introductory Remarks
    David Schoneker IPEC-Americas, Black Diamond Regulatory Consulting, Chair – PQRI EI Workshop Organizing Committee
• Current State of Implementation of ICH Q3D Globally
  • Global Experience/Survey Results
    Janeen Skutnik Wilkinson, Biogen, Chair – IPEC-Americas
  • Implementation of ICH Q3D in Japan
    Yoshiaki Ogasawara, IPEC Japan
  • Implementation of ICH Q3D in India
    Vishakha Metkar, IPEC India, Colorcon Asia Pvt Ltd.

View Recording of Session 1.   (Password: PQRIEI2020)

Session 2

• Regulator Experience – Quality of Risk Assessments and Supporting Data
  • Implementation in the US – FDA Perspective
    Matthew Vera, Ph.D., US Food and Drug Administration
  • Implementation in Europe – EMA Perspective
    Sophie Bertilsson, Ph.D., Swedish Medical Products Agency
  • Q&A Session

View recording of Session 2.(Password: PQRIEI2020)

Session 3

• Industry Experience – Implementation Challenges
  • Recent Experiences with Global Implementation of the Principles of ICH Q3D
    Mark G. Schweitzer, Ph.D., Novartis
  • Industry Implementation Challenges – Excipient Company Experience
    Priscilla Zawislak, DuPont Nutrition and Biosciences
• Pharmacopeia Approaches to Element Specific Requirements in Monographs
  • An Update on USP Element Specific Chapters
    Nancy Lewen, Consultant
  • USP Update on Draft Roadmap for Addressing Element-Specific Chapters and Tests in Excipient Monographs
    Galina Holloway, Ph.D., USP
  • European Pharmacopoeia Activities on Elemental Impurities – An Update
    Ulrich Rose, Ph.D., EDQM

View recording of Session 3. (Password: PQRIEI2020)

Session 4

• Industry Perspectives and Consequences
  • ICH Q3D Industry Perspective and Consequences
    William Dale Carter, MS, Evonik Corporation
  • An Industry Perspective on Managing Specific Elements in Public Standards
    Philip Travis, BSc., Merck and Co., Inc.

View recording of Session 4. (Password: PQRIEI2020)

• Breakout Session 1 – Implementation Problems and Future Needs
  • Moderators: Kathy Ulman, Consultant; Douglas Muse, Eli Lilly and Company; and Janeen Skutnik-Wilkinson, Biogen

Day 2 – Tuesday, November 10, 2020

Session 1

• • Welcome to Day 2 and Review of Day 1
    David Schoneker, Black Diamond Regulatory Consulting
• Ongoing ICH Q3D Activities
  • Update on Transdermal Limits
    Andrew Teasdale, Ph.D., AstraZeneca
  • Lhasa Database Update – Industry Data and Use in DP Risk Assessments
    Laurence J. Harris, Ph.D., Pfizer

View recording of Day 2 Session 1.   (Password: PQRIEI2020)

Session 2

• PQRI Phase 2 Elemental Impurities Collaborative Study Results
  • PQRI Phase 2 Elemental Impurities Collaborative Study Purpose and Design
    Donna Seibert, Ph.D., Perrigo
  • Phase 2 Study Method Development and Laboratory Participant Perspective
    Denise McClenathan, Ph.D., Procter & Gamble
  • PQRI Phase 2 Elemental Impurities Collaborative Study Results Review and Publication
    Donna Seibert, Ph.D., Perrigo
  • XRF Results of Phase 2 Collaborative Study
    Glenn Williams, Ph.D. and Thanh Nguyen, Ph.D., Rigaku Americas Corporation

View recording of Day 2 Session 2.(Password: PQRIEI2020)

Session 3

• • Main Take-Aways
    • Statistical Methods in PQRI Interlaboratory Study Report
      Stephen Erickson, Ph.D., RTI International
    • Key Findings
      James Michael Harrington, Ph.D., RTI International
  • Implications for Analytical Testing in Laboratories for Elemental Impurities
    • Implications for Analytical Laboratory Testing
      Francine Walker, SGS Chemical Solutions Ltd.
  • Implications for Risk Assessments
    • Recent Regulatory Filing Experiences Regarding ICH Q3D Implementation
      Xiaoyi Gong, Ph.D., Merck and Co., Inc.

View recording of Day 2 Session 3. (Password: PQRIEI2020)

•  
• Breakout Session 2 – Explore the Impact of the Phase 2 Study on Industry and Regulators
  • Moderators: James Harrington, RTI International; Donna Seibert, Perrigo; and Denise McClenathan, Procter & Gamble
• Closing Remarks
  David Schoneker