Workshop Materials
Presentations
Day 1 – Monday, November 9, 2020
Session 1
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- Welcome and Introductory Remarks
David Schoneker IPEC-Americas, Black Diamond Regulatory Consulting, Chair – PQRI EI Workshop Organizing Committee
- Welcome and Introductory Remarks
- 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.
- Global Experience/Survey Results
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
- Implementation in the US – FDA Perspective
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
- Recent Experiences with Global Implementation of the Principles of ICH Q3D
- 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
- An Update on USP Element Specific Chapters
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.
- ICH Q3D Industry Perspective and Consequences
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
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- Welcome to Day 2 and Review of Day 1
David Schoneker, Black Diamond Regulatory Consulting
- Welcome to Day 2 and Review of Day 1
- 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
- Update on Transdermal Limits
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
- PQRI Phase 2 Elemental Impurities Collaborative Study Purpose and Design
View recording of Day 2 Session 2.(Password: PQRIEI2020)
Session 3
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- 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
- Statistical Methods in PQRI Interlaboratory Study Report
- Implications for Analytical Testing in Laboratories for Elemental Impurities
- Implications for Analytical Laboratory Testing
Francine Walker, SGS Chemical Solutions Ltd.
- Implications for Analytical Laboratory Testing
- Implications for Risk Assessments
- Recent Regulatory Filing Experiences Regarding ICH Q3D Implementation
Xiaoyi Gong, Ph.D., Merck and Co., Inc.
- Recent Regulatory Filing Experiences Regarding ICH Q3D Implementation
- Main Take-Aways
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