Excipients Workshop - Regulatory, Compliance and Bioequivalence

Friday, September 20, 2019 - 8:00am

A joint CSPS/Health Canada/IPEC-Americas Workshop

Presenter(s)

Dave R. Schoneker

Dave headshot
Global Regulatory Director - Strategic Relationships
Colorcon

David R. Schoneker is the Global Regulatory Director for Strategic Relationships at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets. He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University.  His previous position at Colorcon was Director of Quality Assurance and Quality Control.  He has been at Colorcon since 1977.  Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum.  He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT). 

Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee.  He is now serving as the Vice Chair for Science and Regulatory Policy where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve excipient acceptability, safety and global supply chain security.  Mr. Schoneker also Co-Chairs IPEC’s QbD/Product Development Committee, Composition Committee and the IID Working Group.  He also is a member of the Board of Directors of the IPEC Foundation.  He is the Global Expansion Coordinator for the IPEC Federation and has been critically involved in the development of many of the IPEC groups and Partnerships around the world.

He has acted as an interface with many international regulatory agencies and pharmacopeias for the organization.  He previously was the USP Liaison for IPEC-Americas and represented them as a member of the United States Pharmacopeial Convention for many years.  Mr. Schoneker previously coordinated international harmonization efforts for IPEC-Americas and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients.  He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification and the appropriate use of certificates of analysis.  Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients and has been chairing the Coalition for Rational Implementation of the Elemental Impurity Requirements since 2010.

Mr. Schoneker has participated in the area of Color Science for many years and is author of the chapter “Coloring Agents for Use in Pharmaceuticals” in the 4th edition of the Enclyclopedia of Pharmaceutical Technology which was published in 2013.  He has also authored many other excipient quality and safety related papers in various journals and trade magazines. He is currently the President of IACM.  In this role he coordinates IACM’s international regulatory activities related to synthetic and natural colorants for use in foods and drugs and will participate as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA).

Priscilla Zawislak

Global Regulatory Affairs Advocacy Manager
Dupont Nutrition and Biosciences

Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences

Ms. Zawislak has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products.    Priscilla is the Global Regulatory Affairs Advocacy Manager for Dupont’s pharmaceutical and nutrition business.  Her responsibilities include regulatory advocacy for excipients, APIs and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Inc.’s Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products and Quality Manager at FMC BioPolymer (now DuPont Health & Nutrition).

Ms. Zawislak is the Immediate Past Chair of IPEC-Americas, has been a member of IPEC-Americas committees since 2001 and is a member of the Executive Committee.  She is also President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She is an IPEC-Americas representative on several USP related committees including the Excipients Project Team, Compendial Process Improvement Team, General Notices Project Team, has served as Chair for several Stakeholder Forums, and is a Delegate to the USP Convention. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.

Bretta Lichtenhan

Head of Pharma Registrations - Pharma and Food Materials Life Science
MilliporeSigma

Bretta Lichtenhan is Head of Pharma Registrations within the Regulatory organization of the Life Science division of MilliporeSigma.  She manages a global team of regulatory experts, focused on regulatory registration of products such as excipients, active pharmaceutical ingredients (APIs), highly potent APIs, linkers, antibodies & antibody-drug conjugates, and pharmaceutical materials for the (bio-) pharmaceutical industry. She is currently Chair-Elect of IPEC-America’s and has previously held roles within the association such as Vice Chair of Administrative affairs and chair of the Excipient Qualification Committee.  Bretta has also been actively involved in the planning of ExcipientFest Americas (now Excipient World), for the last several years.  She has over 20 years of experience in the industry with previous experience at Biopharma companies Genzyme (a Sanofi Company) and Percivia LLC.  Bretta has worked for MilliporeSigma for over 9 years in various roles from R&D Product Development, Product Management, Regulatory Affairs and Business Development.  Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master of Biotechnology Engineering from Tufts University.

Janeen SkutnikWilkinson

Regulatory Intelligence and Pharmacopoeial Affairs
Biogen

Ms. Skutnik-Wilkinson is currently with BIOGEN where she is responsible for Regulatory Intelligence and Pharmacopoeial Affairs. Previously she was the Vice President of NSF Health Sciences Pharma-Biotech. Before that, she was the Director of Quality Strategy at Pfizer, and was responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues on a global scale. Janeen has over 22 years of experience and expertise in compendial activities, quality and regulatory policy. She also has held a variety of positions spanning from responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik-Wilkinson earned a Bachelors of Science from the University of Connecticut in 1994. Ms. Skutnik-Wilkinson is Past-Chair of the International Pharmaceutical Excipients Federation (IPEC Fed). She is also past-Chair of IPEC-Americas and served as Chair of IPEC Compendial Review/Harmonization Workgroup (1999 – 2007). She sits on the ICH Assembly (formerly known as the steering committee) as a representative for IPEC Federation, and is also actively involved in PDA, PhRMA and BPOG.

Nigel Langley

Director Technical Service and Scientific Affairs
BASF Pharma Solutions

Nigel Langley

 

Nigel Langley–Director Technical Service and Scientific Affairs, BASF Pharma Solutions, provides technical support to the pharmaceutical industry and helps solve drug development challenges with BASF's platform solutions. Prior to joining BASF Nigel worked for Croda Inc. as Technical Director Health Care, responsible for product and application development for both dietary supplements and Pharmaceutical excipients (liquid dosage). He has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (Liquid Crystals) from the University of Hull, (UK) and an MBA from Leeds University (UK). Nigel has been a member of the Executive Committee at IPEC Americas since 2010 and is currently VC Membership. He is also helping to lead the Novel Excipients initiative for IPEC Americas in collaboration with the IQ Pharma Consortium.

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org