How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

  • Speaker:Dr. David Lim
  • Date: 14th March 2018 09:00 AM PST | 12:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90240

$189

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If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications.

Description:

 

The United States Food and Drug Administration (FDA) approves news drugs and generic drugs under distinct regulatory pathways covered under Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA or the Act). 


In this conference, the regulatory pathways, 505(b)2 for NDAs and 505(j) for ANDAs, will be discussed. For firms to bring certain new and generic drug products into the US market, it is critical to understand how to best use the distinct regulatory pathways.

 

This seminar will help you better understand FDA’s regulatory pathways under sections of 505(b)2 and 505(j) of the FDCA.  This conference will provide a great opportunity to consider and use the regulatory pathways from practical and business perspectives.

 

Areas Covered:

 

  • Applicable Laws and Regulations
  • Definitions
  • 505(b)2 and 505(j) Requirements
  • CMC Requirements
  • Drug Examples Approved under 505(b)2 and 505(j)
  • Important Considerations
  • Best Practices: Dos and Don’ts
  • Speaker’s PASS-IT Recommendations 

Who will benefit:

 

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA Drug Regulatory Pathways 

Instructor Profile: 

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor.  Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.  

Available Options

Live Meeting Access: Attend the meeting Live via Webex

$189

Recording: Access it for 6 months from any location

$259

CD: Shipped within 2 working days

$349

Live + Recording: Attend Live + Access the recording for 6 months

$289

Live + CD: Attend Live + Get a copy of the CD of the webinar

$389

5 Member Group: Access the Live Meeting online from any location globally

$809

10 Member group: Access the Live Meeting online from any location globally

$1,469
For discounts and offers call support

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