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Overview of Excipient Laws and Regulations in Europe

Description

This webinar is intended to provide a road map for how the regulatory process in Europe works relative to the use of excipients with a focus on requirements for:
1. Excipient manufacturers/suppliers
2. Drug manufacturer/excipient users
3. European regulatory bodies and competent authorities

Contributors

  • Dr. Johanna Eisele

    Global Head of Regulatory Affairs, Business Line Health Care, Evonik Operations GmbH

    Dr Eisele is Head of Regulatory Affairs of Pharma Polymers, an Evonik business selling acrylic and biodegradable excipients for oral, dermal, and parenteral applications and for medical devices. Since April 2020 she assumed an additional responsibility as Global Head of Regulatory Affairs Health Care in the Evonik Operations GmbH, Division Nutrition & Care. In this role she is responsible for the regulatory strategy and compliance the division’s APIs, excipients, food ingredients and raw materials for medical devices.

    Johanna Eisele represents Evonik Industries at the IPEC and is chairing IPEC Europe’s Quality and Regulatory Affairs Committee. She graduated in Veterinary Medicines from Gießen University, Germany in 1989 and Veterinary Doctor Title was granted in 1992.

  • Ms. Yasemin Koybasi

    Global Regulatory and Scientific Affairs Senior Manager, Kerry Applied Health and Nutrition

    Yasemin Koybasi – Global Regulatory and Scientific Affairs Senior Manager within Kerry`s Applied Health and Nutrition. She has responsibility to ensure products are manufactured and marketed in line with appropriate legislations across globally in a range of highly regulated framework. Yasemin has more than 15 years of comprehensive experience in the areas of regulatory affairs, she is skilled at collecting and analysing regulatory information, communicating with all organisational levels in cross functional teams and developing strategic regulatory plans. She has a Bachelor`s degree in Chemistry and Master of Science degree in Organic chemistry.


November 16, 2021
Tue 9:00 AM EST

Duration 2H 0M

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