IPEC India's virtual training series to focus on key global excipient regulations for generic drug development

he International Pharmaceutical Excipients Council (IPEC) India will host a virtual training series on February 9, 14, and 15, 2023, with a focus on key global excipient regulations for generic drug development. Relevant subjects such as regulations or guidances that actually apply to excipients and what do not, and what is the excipient manufacturer's and user's responsibility, among others, will be debated at the training series, which will be led by a well-known international faculty in the excipient segment, David Schoneker. This training is only available in India.

The training would cover topics such as excipients for pharmaceutical formulations: key selection criteria, excipient realities, raw material diversity, manufacturing scale, and the differences between excipients and APIs. Topics such as the importance of using high-quality excipients and suppliers in drug formulations will be covered, as will the user's responsibilities, the maker's responsibilities, target market regulatory requirements, regulatory agency expectations and requirements (US, EU, Japan, China), and excipient safety and risk assessment.

The topics also include deliberating on the impact of poor excipient/supplier selection decisions – a focus on cost as a major factor is what usually gets pharma companies in trouble, excipient GMPs and supply chain security, existing excipient GMP and GDP Standards, excipient GMP/GDP Certification, complexity of global excipient supply chains, need for an Excipient Pedigree, excipient supplier support for critical regulations, residual solvents, elemental impurities and NDMA, EU TiO2 ban for Foods – The Facts Regarding TiO2 Safety, potential impact on pharmaceuticals, excipient safety justification in ANDAs - Inactive Ingredient Database (IID), overview of the current IID database, excipient nomenclature issues, use of appropriate excipient grade information for IID references, maximum potency and maximum daily exposure, use of controlled correspondence, building high quality bridging arguments – case studies, excipient safety studies, IPEC Excipient Safety Guide, Excipient Drug Master Files and facts about the need and use of DMFs. David R. Schoneker is the President/Owner of Black Diamond Regulatory Consulting, LLC, a firm that specialises in regulatory and quality consulting for the pharmaceutical, dietary supplement, food, and related industries.

The firm offers expert advice and training on excipient and food additive regulatory, quality, and supply chain issues. With over 45 years of experience in these fields, he has built strong relationships with trade associations, regulatory agencies, and pharmacopoeias all over the world. He is also an Adjunct Professor at Temple University's School of Pharmacy, where he teaches courses in Global Excipient Regulations and Dietary Supplement Regulation. Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. He was at Colorcon from 1977 until 2019. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently an Emeritus member of the Executive Committee, 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.

Schoneker also Chairs IPEC’s QbD/Composition Committee, participates in the IID Working Group and is a member of the Board of Directors of the IPEC Foundation. He previously was the Global Expansion Coordinator for the IPEC Federation and was critically involved in the development of many of the IPEC regional groups and partnerships around the world. Schoneker was the President of the International Association of Color Manufacturers (IACM) in 2019 and was on the IACM Board for many years. In these roles he coordinated IACM’s international regulatory activities related to Synthetic and Natural colorants for use in foods, dietary supplements and drugs and participated as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA) for several years.