Regulatory Requirements for Drugs & Biologics

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.

Note: Some background in science is presumed but is not required.

Course Number: BIOL-40102
Credit: 2.50 unit(s)
Related Certificate Programs: Regulatory Affairs Essentials

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1/9/2023 - 3/13/2023

$675

Online

Closed

• SECTION ID:

  169255

• 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.

• INSTRUCTOR:

  Nayyar, Naresh

  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 submissio...Read More

• TEXTBOOKS:

  No information available at this time.

• POLICIES:

  No refunds after: 1/16/2023.
  

• NOTE:

• DATE & LOCATION:

  1/9/2023 - 3/13/2023
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

4/3/2023 - 6/5/2023

$675

Online

Add To Cart

• SECTION ID:

  171915

• 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.

• INSTRUCTOR:

  Nayyar, Naresh

  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 submissio...Read More

• TEXTBOOKS:

  No information available at this time.

• POLICIES:

• NOTE:

• DATE & LOCATION:

  4/3/2023 - 6/5/2023
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.