PQRI/USP Workshop on ICH Q3D Elemental Impurities Requirements – Presentations

David R. Schoneker, Colorcon, IPEC-Americas,

PQRI Steering Committee, EI Coalition

• FDA Guidance & Current Experience with New Drug Submissions
  • Danae Christodoulou (US Food and Drug Administration)
• EMA Guidance & Current Experience with New Drug Submissions
  • Sven-Erik Hillver (Medical Products Agency (MPA), ICH Q3D IWG)
• Health Canada’s Experience When Implementing the ICH Q3D Elemental Impurity Guidance for NDSs and ANDSs
  • Alison Ingham (Health Canada)
• Current Status and Experience with New Drug Submissions in Japan
  • Akihiko Hirose (National Institute of Health Sciences (NIHS), ICH Q3D EWG)

ICH Perspective

• Global Developments for Elemental Impurity Requirements
  • Janeen Skutnik (Biogen, ICH Q3D IWG)
• Elemental Impurities and Animal Drugs – An Update from CVM
  • Michael R. Brent (Center for Veterinary Medicine, FDA)
• ICH Q3D Expert Working Group: Update on Cutaneous and Transdermal Routes
  • Tim McGovern (Food and Drug Administration, ICH Q3D Rapporteur)

• Specific Elements in Monographs
  • Implementation of the ICH Q3D Guideline in the Ph.Eur. – Bruno Spieldenner (EDQM)
  • Implementation of ICH Q3D in the Certification Procedure -Cristian Sampaolesi (EDQM)
  • USP – Nancy Lewen (Bristol-Myers Squibb)
• USP <661.1>, <381> and <665> and Other Related Chapters
  • Industry Perspective – Timothy Shelbourn (Eli Lilly and Company, IQ Consortium)
  • Extractable Element Testing in USP Packaging Chapters:  Current USP Perspective – Diane Paskiet (West Pharmaceutical Services, USP Packaging & Distribution Executive Committee)
• USP <2232> Elemental Contaminants in Dietary Supplements
  • USP Perspective – Kit S. Goldman (USP)
  • Elemental Impurities Testing Challenges in Dietary Supplements – Tara Lin Couch (EAS Consulting Group, LLC)

Breakout Session I:  Topic: ICH, Regulatory Guidance and Compendial Issues – Areas Requiring Clarification

Facilitators: Priscilla Zawislak (lead), Tim McGovern, Denise McClenathan

• OTC Lifecycle Program – Implementation Strategy & Challenges
  • David Fillar (Perrigo Co)
• Existing Prescription Drug Challenges
  • Development of Elemental Impurity Risk Assessments for Existing Prescription Products – Mark Schweitzer (Novartis, ICH Q3D EWG)
  • Elemental Impurities Program in Teva –Challenges and Expectations – Orit Schwartz – (Teva Pharmaceutical Industries Ltd.)

• US. Industry Experience
  • ICH Q3D Risk Assessment: Regulatory Success and Standardized Methodology for New Filings – William Stevens (Merck & Co., Inc.)
  • Generic Industry Experience with Implementation for New Drug Applications since June 2016 – Ravi Harapanhalli – (Amneal Pharmaceuticals)
• EU Industry Experience
  • ICH Q3D Implementation:  An Innovator’s Experience – Helmut Rockstroh ( Hoffmann-La Roche Ltd)
• Canadian Industry Experience
  • Canadian Submission – Parenteral Drug Product – Joy Mason (Eli Lily and Company)
  • Generic Industry Perspective – Elisabeth Kovacs (Apotex Inc.)
    

Breakout II:  Topic: Industry Experience with Previous Submissions on New Drugs and Concerns about Implementation for Existing Drugs (Includes Global Concerns)

Facilitators: Kathy Ulman (lead), Mark Schweitzer, David Fillar

• Source of EI Data and Information
  • Limited Supplier Information – Varies from Supplier to Supplier
    • Approaches to Elemental Impurity Product Risk Assessments with Limited Supplier Information – Mark Schweitzer (Novartis)
    • Maker Perspective – George Collins (Vanderbilt Chemicals LLC)
  • Literature and Database Information – How Applicable is it to the Grades of Ingredients used in YOUR Formulation??
    • Lhasa Database Update – John Glennon (GSK)
    • Use of Literature and Database Information – A Regulator View – Sven-Erik Hillver (MPA, ICH Q3D IWG)
  • EI Testing performed by the Pharmaceutical Company – Nancy Lewen (BMS)

• PQRI Technical Analytical Challenges Round 2 Interlaboratory Study: Progress and Early Findings
  • Donna Seibert (Perrigo) & James Harrington (RTI International)
• Key Issues Related to Sample Preparation, Interferences and Variability
  • Timothy Shelbourn (Eli Lilly and Company)
• Analytical Challenges for Q3D Implementation: Elemental Analysis by ICP-MS
  • Xiaodong Bu (Merck & Co., Inc.)
• Validation and Compliance – An Analytical Perspective
  • Francine Walker (Chemical Solutions Ltd.)

Breakout Session III Topic: Acceptable Risk Assessment Strategies & Outstanding Analytical Challenges
Facilitators: Nancy Lewen (lead), Tim Shelbourn, Josh Foote

• Breakout I
• Breakout II
• Breakout III