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Webinar: Navigating regulatory affairs challenges for successful drugs

Anja Erdin · Expert Manager RA · Anja Erdin completed her German State exam in food chemistry and received her official certification as Food chemist from CVUA Münster in 2001. She joined Bachem as a regulatory affairs specialist and became a group leader in 2009. As a group leader, she focused on NCE Development and assisting customers with navigating regulatory challenges throughout the lifecycle of their product. Tycho Leifels · Director Product Management · Dr. Tycho Leifels received his PhD in organic chemistry from ETH Zurich in 1999 ...

Andrew Lennard, PhD | ISPE | International Society for Pharmaceutical Engineering

Andrew C. Lennard, PhD, is in Amgen’s External Engagement and Advocacy team within CMC Regulatory Affairs. Prior to joining Amgen, he was a consultant in CMC regulatory affairs. He has 15+ years of...

Director, Regulatory Affairs - Annexon Biosciences

Director, Regulatory Affairs Company: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classi...

Regulatory Education for Industry (REdI) Annual Conference 2022 - 06/06/2022 | FDA

Roule Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 3 Advances in Drug Supply Chain Security – Focus on Distribution Connie Jung, RPh, PhD Captain...

Navigating regulatory affairs challenges for successful drugs

Along their manufacturing journey, many regulatory challenges arise that any successful drug has to pass in order to reach patients in a timely, safe and reliable manner.

FY 2021 Generic Drug Science and Research Initiatives Public Workshop - 06/23/2021 | FDA

Molly Ventrelli, PhD Senior VP, Regulatory Affairs, Fresenius Kabi Janet Vaughn VP Regulatory... of Macau Artificial Intelligence in Generic Drug Development – Experience and...

Regulatory Education for Industry (REdI) Annual Conference 2023 - 06/05/2023 | FDA

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FD...

Expert Regulatory Affairs Consulting Services

Our Regulatory Affairs Consulting team offers standalone services and integrated support from product development to commercial and lifecycle maintenance.

Regulatory Education for Industry (REdI) Annual Conference 2021 - 07/19/2021 | FDA

Patrizia Cavazzoni, MD Director Center for Drug Evaluation and Research (CDER) ; Jeff Shuren, MD, JD Director Center for Devices and Radiological Health (CDRH) ; Peter Marks, MD, PhD Director Center for Biologics Evaluation and Research (CBER)

MS in Biomedical Regulatory Affairs - Seattle,School of Pharmacy

The University of Washington’s Master of Science in Biomedical Regulatory Affairs trains professionals to effectively manage the process of bringing new medical products to market. In this two-year...

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