IPEC-Americas, SOCMA's Bulk Pharmaceutical Task Force, and CHPA Sponsor ICH Q3D Metal Impurities Workshop
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April 4 – 5, 2012
Marriott Bethesda North Hotel, Bethesda, Maryland

IPEC-Americas, SOCMA's BPTF (Society of Chemical Manufacturers and Affiliates Bulk Pharmaceutical Task Force) and CHPA (Consumer Healthcare Products Association) plan to offer a workshop to discuss the ICH Q3D Metal Impurities Guideline. New limits for element impurities in drug products are being recommended that may have a direct impact on your business.

Join us on April 4 & 5 at the Marriott Bethesda North hotel in Bethesda, Maryland! Program outline and speakers update is shown below. This workshop will offer an opportunity to confidentially share data and actual excipient and API samples and then have it taken back to ICH for consideration.

Why you should attend:

• Explore how the new ICH Q3D Metal Limits Guide may impact your drug product;
• Have a voice – you can help determine the outcome;
• Bring data on actual levels in existing products that will be affected by the new limits;
• Equally important to suppliers and users of pharmaceutical ingredients!

Draft Program Sessions:

Day 1
9:00 am - 10:15 am - Plenary Session
Setting the Stage & Q&A: Speakers from IPEC-Americas and the ICH Expert Working Group (EWG) will discuss the draft guideline, implications data will have; impact on pharmaceuticals.

• Janeen Skutnik-Wilkinson, Director, Quality and Regulatory Policy, Pfizer Inc. -  
  Excipient User Perspective
• David Schoneker,Director, Global Regulatory Affairs, Colorcon - Excipient Maker Perspective
• SOCMA BPTF Representative - API Maker Perspective
• ICH Q3D EWG Representative - Overview of the draft ICH Q3D Guideline 
 
10:15 - 10: 30 am - Refreshment & Networking Break

10:30 am - 11:45 am - Technical Session - What Metal Impurities exist in Drug Products and Excipients?

Speakers from IPEC-Americas and the FDA will discuss actual finished drug and excipient data on metal impurities, implications the data will have; impact on pharmaceuticals
• John Kauffman, Ph.D., Research Chemist, (FDA) - FDA Survey Information on Finished Drug Products and Excipients - Metal Impurity levels which are routinely present in commercial materials
• Priscilla Zawislak, Global Regulatory Affairs Manager, Ashland, Inc. - Actual Excipient Test Data on Metal Impurities submitted to IPEC Americas from industry

11:45 am – 1:00 pm Networking Luncheon

1:00 pm – 2:15 pm Technical Session - What Metal Impurities exist in APIs?

Open Forum Q&A: Speaker from SOCMA's BPTF will discuss the draft guideline, actual API data on metal impurities, implications the data will have; impact on pharmaceuticals PLUS Q&A session on all topics discussed in the Plenary and Technical Sessions

• Brant Zell, VP & Global Director, Quality, PolyPeptide Laboratories & Group - Actual API Test Data on Metal Impurities compiled by SOCMA BPTF
• Q&A - Discuss the data presented and possible concerns related to the impact for implementation of the ICH Q3D guideline 

2:15 pm – 3:15pm Breakout Session A, B, C

Breakout Sessions A, B, C 

Breakout Session A - Risk Based Assessment and Control Strategy Development
 
Breakout Session B - Methodology & Bioavailability Issues
- Sample Preparation - Acid extractable vs. total dissolution
- Limits of Detection

Breakout Session C - Communication Tools for sharing information about metal impurities between makers, users and regulators. Includes discussion of timing needed for implementation of ICH Q3D

3:15 pm – 3:45 pm Refreshment & Networking Break
3:45 pm– 4:45 pm Breakout Session A, B, C

Day 2
9:00 am – 10:00 am Breakout Session A, B, C

10:00 am - 10:30 am Refreshment & Networking Break

10:30 am - 11:15 am Roundtable Discussion:
Viewpoints of Key Associations & Regulators

11:15 am – 12:30 pm Summary of Breakouts and Closing Remarks
 

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