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 Educational 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 Leaders: Meera Raghuram is currently Manager for Global Regulatory Affairs and Strategies with the Life Sciences Division of Lubrizol Corporation. In her current role at Lubrizol, she is responsible for developing and executing proactive strategies for inactive ingredients and novel excipients in the pharmaceutical drug, medical devices and in drug/device combination products. She has over 20 years of experience working in the chemical industry and consulting in varied regulatory disciplines.
She has extensive experience in human health and environmental risk assessments of chemical products and has been involved with industry organizations including the American Chemistr
y Council and ASTM. In her previous position, she was responsible for management of remediation liability for Lubrizol and has successfully worked with
US (state and federal) and international regulatory agencies to bring resolution to issues. Meera has a B.S degree from the Indian Institute of Technology and a M.S. in Chemical Carcinogenesis from Purdue University, IN. She is the current chair of the IPEC Americas Regulatory Affairs Committee.

Kathy Ulman recently retired from Dow Corning Corporation after more than 35 years. She is currently their Global
Regulatory Compliance Manager and Associate Scientist. Much of her earlier career was dedicated to the synthesis of novel silicone monomers and polymers/copolymers. Ulman is a member of the American Chemical Society, the American Association of Pharmaceutical Scientists and the Control Release Society. As an active member of the International Pharmaceutical Excipient Council (IPEC) Americas, she was recently elected to the organization’s executive board as the vice chair for Science and Regulatory Policy. She has published and presented several papers in her field and has taught international courses on silicones for pharmaceutical/biomedical applications and medical adhesives through
Technomic Publishing Co.

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 is an Associate Director, Compendial Affairs for Merck. She has 36 years of experience at Merck/Schering-Plough Corporation in quality control, analytical development and compendial affairs.  In her role in Compendial Affairs she provides expertise and guidance in all aspects of the compendial issues to ensure compliance with the compendia. She handles correspondence with the compendia. She is a liaison between Merck and the compendia, and also provides guidance to Merck sites on compendial requirements.

Currently Ms. Walsh is the IPEC Executive Committee Vice-Chair for Harmonization and Compendial Monographs and Chair of IPEC – Americas Compendial Review / Harmonization committee.

She is a member of New Jersey Pharmaceutical Quality Control Association (NJPQCA) and served as chair of the NJPQCA Compendial Discussion Group for 14 years. She represented NJPQCA on USP Excipient Project Team, USP Process Improvement Project Team and the USP Biopharmaceutics Project Team which she served as chair. Also she was a member of the USP Advisory Group on Elemental Impurities. She is a member of Coalition on Elemental Impurities.

 

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 will be provided. Participants will 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 Leaders: Bretta Lichtenhanis a Formulation Specialist within the Actives and Formulation division of MilliporeSigma.  She has chaired the IPEC-Americas Excipient Qualification Committee for the last 4 years and is also Vice Chair of Administrative Affairs of IPEC-America’s Executive Committee.  Bretta has been actively involved in the planning of ExcipientFest for the last several years.  She has over 19 years of experience in the industry with previous experience at Biopharma companies Genzyme and Percivia.  Bretta has worked for MilliporeSigma for over 7 years in various roles from R&D Product Development, Product Management, and Regulatory Affairs.  Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master’s of Biotechnology Engineering from Tufts University.

Heather Sturtevant is a Senior Scientist with McNeil Consumer Healthcare within the Technical Operations department. She has worked in the Pharmaceutical Industry for 10 years in Process Development, Technical Transfer and Raw Material Evaluation roles.
She currently Vice Chairs the IPEC Americas Excipient Qualification Committee. She holds a BS in Chemical Engineering from the University of Delaware.


Workshop Abstract:

This workshop will focus on a review of recently published and impending IPEC Guides.  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 of excipient variability on pharmaceutical drug product development

1:00 PM – 4:00 PM

Presented by U.S. Pharmacopeia: 

Workshop Leader: Catherine Sheehan and 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 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 fellow drug product/excipients/raw materials industry professionals, and understand the future direction of USP-NF excipients standards development.

 

Part I (120 mins)

Moderator: Catherine Sheehan, USP

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” (Dr. Richard (Chris) Moreton, Vice Chair, USP Excipient Monographs 1 Expert Committee)
  2. Nomenclature: Critical importance of naming an excipient for pharmaceutical use (Dr. Galina Holloway, USP)
  3. Variability of composition: PQRI update on survey (Dr. Lawrence Block, USP)
  4. Bridging Justifications: Supporting the Safety of Excipients in Generic Drug Products ()

Part II (60 mins)

Updating excipients used in specialized drug delivery systems – variability due to excipient selection

  1. Defining specifications (Dr. John Wang, Genentech)
  2. Subvisible particles in parenterals (Dr. Desmond Hunt, USP)

Part III (30 mins)

Workgroup discussion (30 mins)

Moderator: John Giannone, USP

  1. 1.Variability of raw materials in continuous manufacturing and batch manufacturing
  • Panel members (John Wang, Desmond Hunt, Lawrence Block, Chris Moreton)

 

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 was IPEC Americas Past Chair. He is the Global Director of Quality for the Silica Business Unit of Huber Engineered Materials. He is responsible for quality systems, product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, India, Finland, and China. Prior to joining Huber he was the Manager Product Quality and Management Systems in the Office of Compliance and Ethics for the Archer Daniels Midland Company where he supported processing and business operations in the development and improvement of quality management systems to ensure sustainable quality, regulatory compliance, effective risk management, and customer satisfaction. With ADM he supported excipients, bulk APIs, food ingredients, dietary supplement ingredients, biofuels, animal feeds, and specialty grains products. He holds a Bachelors of Science degree from Davidson College in Chemistry and a Master’s of Science degree from North Carolina State University in Chemistry. He is a frequent ExcipientFest speaker.

Workshop Abstract: This workshop will review the key steps for implementing Excipient GMPs that comply with the NSF/IPEC/ANSI 363 and the GMP Standard included in the EXCiPACT TM 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.