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2013 Speakers & Presentations

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EXCIPIENTFEST - Educational Sessions

Visit IPEC's website for Online Presentations


DAY 1 - Tuesday, April 30th

KEYNOTE SPEAKER: Impact of Food and Drug Administration Safety and Innovation Act (FDASIA) on Excipients" Ms. Susan De Mars - FDA Senior Advisor

“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
 
“China Update (Excipient GMP, Import Licenses” Mr. Huimin Sun - NIFDC (China)
“Shellac: a Versatile Film Coating System” Ms. Beverly Schad - Sensient
 
“A New Generation of Directly Compressible Lactose” Mr. Jian-Xin Li – DFE Pharma
“Excipients in Latin America - Highlights” Mr. David Schoneker – IPEC Americas
 

Lunch

“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
 
“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
 

KEY-NOTE SPEAKER: "NSF 363 Draft GMP Standard" Mr. Steven Wolfgang - FDA Invited Speaker

SPEAKERS’ ROUND TABLE:
(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)


DAY 2 - Wednesday, May 1st

KEYNOTE SPEAKER: "Product Quality Informatics: Value and Opportunities" Mr. Lawrence X. Yu – FDA Invited Speaker (IPEC)

“Raw Materials Risk Mitigation” Ms. Charlotte Hicks - Doe & Ingalls
“Performance Excipients as Tools to Promote Robust Drug Products” Mr. James Farina – Avantor Performance Materials
 
“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
 

Lunch

“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
 
“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)
 
“Streamline Solid Dosage Form Development” Mr. Tony Carpanzano – JRS Pharma
“Excipient GMP in China – Manufacturer’s Perspective” Ms. Meredith Ge - IPEC China
 

KEYNOTE SPEAKER: “IPEC-OGD IID Committee Meeting Update” Mr. Naiqi Ya– FDA Invited Speaker - Poster Awards & Closing Remarks

Workshops

Excipient Safety Evaluation - IPEC Americas

IPEC Regulatory Considerations (Dual Session) - IPEC Americas

An Introduction to Drug Development through Design of Experiments - Emerson Resources

Overcoming Challenges in Drug Formulation - BASF Corporation



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