Evonik
Tuesday, November 15, 2022
4:00 p.m. CET / 10:00 a.m. EST

Evaluating toxicological risk along the product lifecycle of an HPAPI – a CDMO perspective

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Overview

Working with HPAPIs requires a deep understanding of the complexities and liabilities involved. Investment to ensure employees and their environment are protected from exposure is a must.

In this first sesision of our new HPAPI webinar series, our product stewardship toxicologists, Dr. Daniel Bertow and Dr. Andrea Marburger, start you off on the journey of assessing the risks of new and marketed chemical entity APIs and the associated intermediates. Drawing on years of experience, our speakers provide you with an understanding of the workflow, evaluation process, software and studies typically utilized, as well as key information needed to make a formal assessment of safe handling procedures.

This webinar is suitable for anyone working in procurement, outsourcing, EHS, quality assurance, or as a project manager, who is interested in understanding the whole assessment process and their role in it.

Key learnings for participants of this webinar:
  • Overview of established methodology and benchmarking within the pharma industry
  • Understanding data requirements for sustainable and high-quality safety assessments

Experts featuring this session

Dr. Andrea Marburger
Hazard & Risk Management - Product Stewardship
Evonik Health Care

Vita
Andrea began her career in toxicology as a study director in two contract research organizations followed by eight years as a toxicologist in the pharmaceutical industry and four years in a scientific consulting company.

She joined Evonik in 2020 and has held different positions working in the derivation of occupational exposure limits (OELs) and permitted daily exposures (PDEs). She also has over 10 years’ experience in health hazard assessments of impurities and contaminations.

Andrea originally trained as a veterinary surgeon before completing a Ph.D. and post-doctoral research.
Dr. Daniel Bertow
Hazard & Risk Management - Product Stewardship
Evonik Health Care

Vita
Daniel has more than 15 years’ professional experience in the field of human health risk assessment. He joined Evonik in 2009 and has contributed his toxicological expertise to various regulatory fields.

His main focus has been on deriving OELs (occupational exposure limits) and PDEs/ADEs (permitted/acceptable daily exposures). In addition, he has experience in the preparation of impurity and contamination assessments.

Daniel holds a Ph.D. in food toxicology and is a registered toxicologist (DABT).

Related webinars in this series

This is the first webinar of our 3-part webinar series entitled "Handling HPAPIs: From toxicological risk assessment to metric ton manufacturing". Join us to follow the journey of a highly potent molecule, starting from toxicological assessment to initial tech transfer and development onto large scale (metric ton) commercial manufacture.

To learn more about the two other webinars in this series please click on the respective webinar below. To register for multiple webinars of this series simply select them in the registration form.

  • HPAPI process development and pilot-lab implementation
    Tuesday, December 6, 2022 | 10:00 AM (EST) / 4:00 PM (CET)

  • Manufacturing metric tons of HPAPIs: what does success look like?
    Tuesday, January 24, 2023 | 10:00 AM (EST) / 4:00 PM (CET)

Register now

Details

Webinar language
English

Venue

Online

Questions?

Julia Born
Market Communications Health Care
+49 6151 18 4984 E-Mail
Register now
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