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Course

Regulatory Requirements for Drugs & Biologics

BIOL-40102

Discover the FDA regulatory requirements as they pertain to biotech and pharmaceutical companies. In this course, you will review topics such as: FDA organization and operations; U.S. Pharmacopoeial convention; INDs; the product development process; product characterization and pre-clinical evaluation; pharmacology/toxicology for new drugs and GLPs; clinical investigations, bioresearch monitoring and GCPs; and CMC requirements and GMPs. Also covered are the roles that regulatory affairs professionals play in the process.

Course Information

Online
2.50 units
$675.00
Notes: Some background in science is presumed but is not required.

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This course applies to these programs

Regulatory Affairs Essentials ADMET in Drug Development

Course sessions

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Section ID:

190468

Class type:

Online Asynchronous.

This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

Textbooks:

No textbook required.

Policies:

  • No refunds after: 6/30/2025

Schedule:

No information available at this time.
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Instructor: Naresh Nayyar

Naresh Nayyar
Naresh Nayyar, Ph.D., is an experienced regulatory affairs leader with broad experience in clinical/companion diagnostic/CMC and post approval drug development activities. These includes EU MAA, BLA, sNDA (e.g. Herceptin SC, MabThera SC, Rituxan Hycela, HyQvia and Hylenex) approvals including multiple post-approval supplements. Currently he is Associate Vice President of Regulatory and Quality at aTyr Pharma.  During his 20+ year career he has worked in small and large pharmaceutical companies, including Agouron, Pfizer, Spectrum, and Halozyme.  Naresh Nayyar is experienced in preparing teams for regulatory agency meetings (Pre-IND, Type B/C, EOP2, pre-NDA, and Clarification Meetings), managing interface with agencies, organizing regulatory agency meetings, preparing submissions, and negotiating and interacting with US and international regulatory agencies.
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