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DAY 1 Tuesday, April 29th
From 7:00 AM Registration, Coffee & Pastries  
  Conference Hall A (Expo Area) Conference Hall B (Expo Area) 
 

Welcome Speech

Mr. Dwight Mutchler - ExcipientFest President and Mr. John Giannone - IPEC Americas Chair

 
 8:30 – 9:15 AM

KEYNOTE SPEAKER: “Impact of Food and Drug Administration Safety and Innovation Act (FDASIA) on Excipients"

Ms. Susan De Mars - FDA Senior Advisor

 
 9:15 – 10:00 AM  

“The Story of Magnesium Stearate as a Powder and Tablet Lubricant”

Mr. Doug Lugge – Covidien Mallinckrodt

 

“Impact of FDASIA on Excipients Industry Perspective / Atypical Actives”

Ms. Priscilla Zawislak – IPEC Americas

 10:00 – 10:45 PM

“China Update (Excipient GMP, Import Licenses”

Mr. Huimin Sun - NIFDC (China)

“Shellac: a Versatile Film Coating System”

Ms. Beverly Schad- Sensient

 10:45 – 11:15 AM  Coffee & Networking Break  
 11:15 – 12:00 PM

“A New Generation of Directly Compressible Lactose”

Mr. Jian-Xin Li– DFE Pharma

“Excipients in Latin America - Highlights”

Mr. David Schoneker – IPEC Americas

 12:00 – 1:30 PM  Lunch and Networking at Baltimore Ball Room  
 1:30 – 2:15 PM  

“Quality by Design Principles for Film Coating and Hydrophilic Matrix Applications”

Ms. Laura Scattergood and Mr. Gus LaBella – Colorcon

 

“Coalition for the Rational Implementation of the USP Elemental Impurities Requirements”

Ms. Katherine Ulman – IPEC Americas

 2:15 PM – 3:00 PM  

“Changing Regulations, Expectations of Excipients and Tools for Ensuring Quality of the Supply Chain”

Ms. Lori Bestervelt – NSF International

 

“Meeting the Challenges in New Excipient Development”

Mr. Joseph Zeleznik - Meggle

 3:00 PM – 3:45 PM  Coffee Break & Networking Break  
 3:45 PM – 4:15 PM

KEYNOTE SPEAKER: “NSF 363 Draft GMP Standard"

Mr. Steven Wolfgang - FDA Invited Speaker

 
 4:15 – 5:00 PM  SPEAKERS’ ROUND TABLE:  “Risk Assessment and Excipients” (Moderated by Patricia Van Arnum - Pharmaceutical Technology)
Irwin Silverstein (IPEA), Janeen Skutnik (NSF), Meera Raghuram (Lubrizol), Frank Milek (Hedinger, IPEC Europe Chair), Dale Carter (JM Huber), Steven Wolfgang (FDA)
 
 5:00  – 7:00 PM  ExcipientFest Cocktail with Live Music  
     
     
     
     
DAY 2 Wednesday, May 1st
From 7:00 AM  Registration, Coffee & Local Pastries  
   Conference Hall A Conference Hall B
 9:00 – 9:45 AM

KEYNOTE SPEAKER: "Product Quality Informatics: Value and Opportunities"

Mr. Lawrence X. Yu – FDA Invited Speaker (IPEC)

 
 9:45 – 10:30 AM  Coffee Break & Networking Break  
 10:30 – 11:15 AM

“Raw Materials Risk Mitigation”

Ms. Charlotte Hicks - Doe & Ingalls

“Performance Excipients as Tools to Promote Robust Drug Products”

Mr. James Farina– Avantor Performance Materials

 11:15 – 12:00 PM

“Elemental Impurities – Excipient Realities and Challenges”

Mr. David Schoneker – IPEC Americas

“Europe  Update - Falsified Medicines Directive / WHO World Pharmacopoeia”

 Ms. Janeen Skutnik -  IPEC Federation and Mr. Frank Milek – IPEC Europe

 
12:00 – 1:30 PM
 Lunch and Networking at Baltimore Ball Room  
 1:30 – 2:15 PM

“IPEC's Typical Visible Particle Profile Guideline”

Ms. Ann van Meter – IPEC Americas

“USP updates on Excipient monograph modernization and FDA Modernization Task Group list”

Ms. Catherine Sheehan - US Pharmacopeia

 2:15 - 3:00 PM

“Approaches to the Formulation of Poorly Soluble Drugs”

Mr. Chris Moreton – IPEC Americas

"How Sweet is the Medication? A Robust Encapsulation Solution with Focus on Pediatric Dosage Delivery”

Mr. Ashish Joshi – Roquette Americas

3:00 – 3:30 PM  Coffee Break & Networking Break  
 3:30 – 4:15 PM

“Streamline Solid Dosage Form Development”

Mr. Tony Carpanzano – JRS Pharma

“Excipient GMP in China – Manufacturer’s Perspective”

Ms. Meredith Ge - IPEC China

 4:15 – 5:00PM

KEYNOTE SPEAKER:  “IPEC-OGD IID Committee Meeting Update”

Mr. Naiqi Ya– FDA Invited Speaker

Poster Awards & Closing Remarks

 
 5:00  – 7:00 PM  ExcipientFest Cocktail with Live Music  
     
     
     
     
     
     

This program is subject to change. Please refer to this website for updates.