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.

Join us on Thursday, August 4 at 1:00 pm ET for critical insights and key considerations for selecting the best regulatory pathway to ensure success for new drug applications (NDA) submissions. Explore the latest strategies for advancing ANDA and 505(b)(2) submissions with Sharon Ayd, Ph.D., Vice President & Principal Regulatory Center of Excellence (CoE) Advarra Consulting.

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

Presented By

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Sharon Ayd

Ph.D, MBA

Vice President & Principal
Advarra Consulting

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Who should watch?

This content applies to sponsors and CROs at growing biopharma and pharma companies. It also contains relevant insight for early-stage companies, biologics, and emerging biotech companies. Anyone involved at any product development stage in advancing investigational new drugs (IND) to market at clinical research organizations.

CE Credits

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.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

Register Now