David R. Schoneker

Colorcon, IPEC-Americas,

PQRI Steering Committee

EI Coalition

Industry Perspective

• ICH Q3D Risk Assessment for New Filings – Examples and Regulatory Interactions
  • Andre Hermans (Merck & Co, Inc.)
• Generic Industry Perspective – Experience with a drug filed after June 1, 2016.
  • Marjorie Coppinger (Teva)
• ICH Q3D Guideline – Impact on the Users: Perspective of a Finished Product Manufacturer
  • John Glennon (GlaxoSmithKline)

Regulator Perspective

• FDA Experience When Reviewing NDAs and ANDAs for Q3D Elemental Impurity Compliance
  • Danae Christodoulou (US Food and Drug Administration, EI Implementation Working Group)
• EMA Experience When Reviewing NDAs and ANDAs for Q3D Elemental Impurity Compliance
  • Diana van Riet-Nales (Member Quality Working Party (QWP) European Medicines Agency (EMA) | Senior Assessor department of Chemical Pharmaceutical Assessments (CFB))
• Health Canada’s Experience When Implementing the ICH Q3D Elemental Impurity Guidance for NDSs and ANDSs
  • Alison Ingham (Health Canada)

• Data Sharing Initiatives
  • Andrew Teasdale (Astra Zeneca)
• PQRI Phase 2 Collaborative Study – Current Status and Learnings
  • Donna Seibert (Perrigo)

• Strategies for Determination of Elemental Impurities in Difficult Sample Matrices
  • Denise McClenathan (Procter & Gamble)
• Fundamentals of the ICP-MS technique and How to Resolve Issues for Pharmaceutical Materials
  • Tim Shelbourn (Eli Lilly)
• Analytical Challenges Seen at a Contract Lab and How to Develop a Project Appropriately
  • Samina Hussain (Exova Labs)
• API Testing Requirements to Support the Risk Assessment
  • Elisabeth Corbett (Bristol-Myers Squibb)
• A Supplier’s Strategy for Elemental Testing and Risk Assessment
  • Kathy Ulman (Dow)
• Use of Elemental Analysis Testing by WD-XRF: A Simplified Approach
  • Glenn Williams (Rigaku)

Topic: Regulatory Filing Observations for New Drugs

Topic: Analytical Testing Considerations – Data Sharing ad Collaborative Studies

David R. Schoneker, Colorcon, IPEC-Americas,

PQRI Steering Committee // EI Coalition

• Case study – Oral Solid & Liquid dosage forms which contains excipients derived from natural and mined excipients
  • Josh Foote (Perrigo Co.)
• Case study – Topical Dosage Form
  • David Fillar (Perrigo Co.)
• Case study – Parenteral Dosage Form- Approaches and Challenges
  • Joy Mason (Eli Lilly and Company)
• Case study – Biological dosage form
  • Peter Colvin (Merck & Co. Inc)

• Final Implementation Plans for USP and PhEur Pharmacopeial Chapters and Notices on Elemental Impurities
  • Kahkashan Zaidi (USP)
  • Bruno Spieldenner (PhEur)
• Life-cycle management
  • Phyllis Walsh (Merck & Co. Inc.)
• Industry Readiness for Implementation of Q3D and Pharmacopeial Chapters to Existing Products
  • Siva Vaithiyalingam (CIPLA)
• Implementation Outside of the U.S. and EU
  • I-Chen Sun (Deputy Director, Center for Drug Evaluation, Taiwan)

Topic: Risk Assessment Approaches that Work

Topic: Preparing for Existing Drug Product Implementation in January 2018

Breakout Session I:             Katherine Ulman, Dow

Breakout Session II:            Nancy Lewen, Bristol-Myers Squibb

Breakout Session III:          Priscilla Zawislak, Consultant

Breakout Session IV:           Phyllis Walsh, Merck & Co. Inc.

David R. Schoneker

Colorcon, IPEC-Americas, PQRI Steering Committee, EI Coalition