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Hotel Info

Media Sponsors

Principal Media Sponsors

Pharmaceutical Technology

American Pharmaceutical Review

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Schedule

WS DAY

Mon. April 24
  • Workshops

DAY 2

Tue. April 25
  • Key-Note Speaker (8:30AM – 9:15AM)
  • Pharma Expo (8:30AM – 6:00PM)
  • Poster Sessions (9:00AM – 6:00PM)
  • Educational Sessions (9:15AM – 3:00PM)
  • Lunch (12:00PM – 1:30PM)
  • Poster Session Q&A (3:00PM – 3:30PM)
  • Key-Note Speaker (3:30PM – 4:15PM)
  • Speakers’ Roundtable (4:15PM – 5:00PM)
  • ExcipientFest Cocktail (5:00PM – 7:00PM)
  • IPEC Soiree

DAY 3

Wed. April 26
  • Pharma Expo (8:30AM – 6:00PM)
  • Poster Sessions and Awards (9:00AM – 6:00PM)
  • Key-Note Speaker (9:00AM – 9:45AM)
  • Educational Sessions (9:45AM – 3:00PM)
  • Lunch & Poster Awards (12:00PM – 1:30PM)
  • Key-Note Speaker (3:15PM – 4:00PM)
  • ExcipientFest Cocktail (4:00PM – 6:00PM

A Two-Day Educational Experience and Pharma Expo with in-depth Workshops and Education Sessions from Industry’s Top-Excipient Experts

Focused Technical and Regulatory Workshops

 

DAY 1 – April 24th  - Monday

I

Excipient Regulatory Issues on Emerging Markets: China, Korea, Brazil

9:00 PM – 12:00 PM

Presented by IPEC Americas: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems.

Workshop Leader: Meera Raghuram and Kathy Ulman

Workshop Abstract: The intent of this workshop is to discuss global regulatory requirements for excipients including technical information, safety and stability data that are minimum requirements for qualification of excipients.  The workshop will focus on China, Korea and Brazil where regulatory requirements for excipients are evolving and are often modeled after Active Pharmaceutical Ingredients (APIs).  Experts will discuss strategic approaches to compiling excipient dossiers to meet both global and regional regulatory requirements. 

 

II

ICH Q3D Elemental Impurities  - Implementation Considerations

9:00 AM – 12:00 PM

Presented by IPEC Americas: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems.

Workshop Leader: Phyllis Walsh

Workshop Abstract: This workshop will discuss the Implementation of ICH Q3D Elemental Impurities. We will cover Regulatory Guidance, Compendial Requirements, Implementation by Regions, and Life cycle management. Also an update on PQRI Phase 2 testing and Risk Assessment approaches being conducted. We will also work through a case study using the Risk assessment approach described in ICH Q3D guidance.

 

 

III

Key New IPEC Guides: What you need to know

9:00 AM – 12:00 PM

Presented by IPEC Americas: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems.

Workshop Leader: Bretta Lichtenhan and Heather Sturtevant

Workshop Abstract:

This workshop will focus on a review of recently published and impending IPEC Guides.  Specifically the following guides will be reviewed:
•             Risk Assessment Guide (pending publication – slated for 2017)
•             Quality Agreement Guide Revision (pending publication – slated for 2017)
•             QbD Sampling Guide (published 2016)
•             Co-Processed Excipients guide (Completed; pending publication 2017)


The presentation of these guides will allow for the audience’s feedback and interaction.  There will also be a group discussion on ideas for future improvements and/or needed guides for topics that are not currently covered. Questions to be addressed include “Which guides would you like to see updated?”  “Which are most valuable?” and “What’s missing that you would like to see?”

 

 

IV

Excipient selection and the impact on excipient variability in pharmaceutical drug product development

1:00 PM – 4:00 PM

Presented by U.S. Pharmacopeia: 

Workshop Leader: John Giannone

Workshop Abstract:Excipient selection is a key issue on drug product development. Excipients are a major component of both medicines and foods, representing a huge impact on global health and safety. At the same time, excipients have perhaps the most diverse supply chain, with great variability in quality and regulatory standards. Excipient selection is critical to formulation design for bioavailability. Variability is a key issue for formulators and manufacturers leading to reformulation and/ or reengineering of the drug product. This workshop will provide an overview of how the quality and variability of excipients currently impact drug product development and manufacturing.  These discussions may help shape future standard development plans for USP in the area of excipients. This workshop will bring together FDA and USP staff and scientific experts from industry to discuss key current issues concerning excipients. Additionally, the workshop will allow attendees to, share ideas on excipients selection, network with colleagues, and with fellow drug product/excipients/raw materials industry professionals, and understand the future direction of USP-NF excipients standards development.

Part I - Excipient selection and impact on final drug product development
1.    Report out of the 2016 FDA-USP Excipient workshop “Critical Importance of Excipients in Product Development Why Excipients are Important Now and In the Future”
2.    Nomenclature: Critical importance of naming an excipient for pharmaceutical use
3.    Variability of composition : PQRI update on survey)


Part II - Updating excipients used in injectable drug products – variability due to excipient selection
1.    Defining specifications
2.    Excipients in Parenteral Drug Products
3.    Sub visible particles in parenterals


Part III - Workgroup discussion (30 mins)
1.   Variability of raw materials in continuous manufacturing and batch manufacturing

 

V

Implementing Excipient GMPs to comply with Certification Standards

1:00 PM – 4:00 PM

Presented by IPEC Americas: The industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems.

Workshop Leader: Dale Carter

Workshop Abstract: This workshop will review the key steps for implanting Excipient GMP that comply with the NSF/IPEC/ANSI 363-2014 and the GMP Standard included in the EXCiPACTTM certification scheme.  Starting at management commitment to the program and continuing through to what to expect during a certification audit, this course will highlight the key points to consider and provide examples for completing the process.  This workshop is targeted  toward both production and quality managers as well as technical service managers who need to justify certification and manage the certification process of an excipient manufacturing facility.