Webinar - IPEC Best Practices Guide for the Safety Evaluation of Pharmaceutical Excipients

Category: IPEC Federation
  • Online event
  • 24 Feb 2022

The webinar will provide an overview of the recently published IPEC Safety Guide for Pharmaceutical Excipients.

The guide was designed to give an overview on recommended toxicological studies for different therapeutic applications, routes of administration and treatment periods. Toxicological safety studies described in this guide are intended for consideration by excipient manufacturers who market excipients for use in drug formulations and excipient users who conduct toxicology studies required for the initial approval of a novel excipient in a drug formulation.  Excipient users formulating an excipient beyond its approved, prior use are responsible for conducting the appropriate safety studies.

This webinar will highlight key sections from the guide.


Learning objectives

The webinar will cover safety considerations based on:

  • degree of excipient novelty
  • duration of intended human exposure
  • route(s) of administration
  • patient population
  • therapeutic application
  • special considerations
  • alternative methods

PRESENTERS

Dr. Stefan Schulte, Director, Regulatory Toxicology, Product Safety, BASF

Dr. Stefan Schulte has currently position as a Director for Regulatory Toxicology in the product safety unit at BASF’s headquarter in Ludwigshafen, Germany.

He completed his studies as a pharmacist at the University of Heidelberg in Germany and received his doctorate in pharmaceutical sciences in 1993 with a dissertation on the neurotoxic effect of certain heavy metals.

Since 1994 he has been working as a regulatory toxicologist in BASF’s central department of product safety. In addition, he worked for five years in BASF’s cosmetic ingredient business unit as a Senior Regulatory Affairs manager.

Overall, Stefan gained as an industry toxicologist and a member of various toxicological expert groups a profound experience in the safety testing and safety evaluation of ingredients for the pharmaceutical, cosmetic, and food industry.

 

Dr. Claas Gronewold, Regulatory Affairs Pharma Polymers, Evonik Nutrition and Care GmbH

Dr. Claas Gronewold is the toxicologist in the Regulatory Affairs Team Pharma Polymers within Evonik Nutrition & Care GmbH in Darmstadt. Beside executing the non-clinical part of submissions to international authorities for Evonik´s pharmaceutical excipients (such as EUDRAGIT® or RESOMER®), he supports the Asian region in regulatory-, safety- or quality-related customer questions.

In 2005 he started his industrial career as safety assessor for cosmetic formulations at Kao Europe Research Laboratories in Darmstadt. During these 12 years in the cosmetic industry, he was chair of the Expert Team (ET) “Inhalation Exposure” under the umbrella of the EU cosmetics association Cosmetics Europe and coauthor of several publications.

In 2017 he started with new challenges in his current position as Senior Manager Regulatory Affairs. In parallel to his professional duties, he attended the advanced training course for toxicologists organized by the German Society for Pharmacology and Toxicology (DGPT) and is registered in the European Register of Toxicologists (ERT) since August 2018.


Registration Fees
IPEC Federation (IPEC-Americas, IPEC Europe, IPEC China, IPEC Japan and IPEC India) Members: free of charge - registration is mandatory.
Are you a member of IPEC Japan, IPEC China or IPEC India? Please contact info@ipec-europe.org for a complimentary registration.
Non Members: 80 € (excl. VAT)