Dr. David Schoneker

Safety by Design – Concepts to Enhance the Development of Drug product which are Designed with Patients Mind. Safety by Design – Conceptos para realizar el desarrollo de productos farmacéuticos diseñados pensando en el paciente


David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments.

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 International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN), the Consumer Health Products Association (CHPA) and the Institute of Food Technologists (IFT).

Mr. Schoneker was the Chairman of IPEC Americas during the period 2007-2009. He is now serving as the Vice Chair of Maker and Distributor Relations where he is actively involved with the development of Excipient GMP and Supplier Qualification related guidelines to improve Global Supply Chain Security. He also Co-Chairs IPEC’s QbD/Product Development Committee and Composition Committee and is a member of the Board of Directors of the IPEC Foundation.

He has acted as an interface with many international regulatory agencies and pharmacopeias for the organization. He has served as the USP Liaison for IPEC Americas in the past and is still actively involved in various activities of the United States Pharmacopeia Convention. Mr.

Schoneker previously coordinated all International Harmonization efforts for the group 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.

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 2nd edition of the Encyclopedia of Pharmaceutical Technology which was published in 2002. He has also authored a number of other excipient quality and safety related papers in various journals and trade magazines.

Mr. Schoneker has also been actively involved in developing various Anti-Counterfeiting Authentication technologies which utilize unique excipient, taggant and colorant solutions for overt and covert on-product authentication.



The U.S. FDA has recently been developing many guidance related to various aspects of  Patient-Focused Drug Development

A number of these guidance deal with various Patient Benefits related to efficacy

However, several of them relate to how drug products and packaging need to be designed to take the patient into consideration, minimize medication errors and improve compliance

Key Design Topics Covered in Guidances So Far:

  • Paediatric Considerations
  • Container and Carton Labelling to Minimize Medication Errors
  • Self-Selection of Medications
  • Tablet and Capsule Design

In these presentation, we will discuss these points and will go deeper in some aspects of how some considerations can affect significantly the efficiency of the treatment by the patient, that is the goal of the whole process.