On-demand Webinar

Regulatory Pathways: When to Submit a 505(b)(2) or an ANDA

Successfully advancing new drugs and life-saving therapies to market for emerging pharma and biotech organizations, involves complex challenges throughout product development. For these companies, choosing the right regulatory pathway can significantly impact the success of bringing innovative therapies to market.

This webinar discusses best practices and key strategies to consider when choosing the best regulatory pathway for new drug application submissions as well as recommends strategies for early-stage biopharma companies to achieve successful outcomes.

Learning Objectives:

  • Gain an in-depth understanding of the ANDA and 505(b)(2) process
  • Learn successful strategies for advancing your NDA submission
  • Understand how to identify and mitigate regulatory risk factors in your go-to-market strategy
  • Understand the importance of developing a regulatory strategy
Sharon Ayd

Sharon Ayd

MA

Vice President & Principal, Advarra Consulting

The Society of Clinical Research Associates (SOCRA – www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

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