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

  • Speaker:Dr. David Lim
  • Duration:60Min
  • Product Code:GRC-90240

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

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

Recording: 6 Months Access to the Training which can be accessed from any location

$279

CD-DVD: Shipped within 2 working days

$389

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,649

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,229

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