The NDA 505(b)(1) Pathway to Regulatory Approval
A critical moment for any biopharma organization in their quest toward research innovation is navigating and prioritizing key regulatory steps to reduce development time, manage risk, and enhance the likelihood of approval.
Staying ahead of the curve means that life sciences companies need to be nimble while integrating a proactive, risk-based approach for their organization, starting with their early product development efforts. The development plan should outline clear milestones along the pathway:
- Non-clinical and clinical development
- Research & Development (formulation and analytical)
- Manufacturing Scale up
- FDA Interaction and communication
- Submission Strategy, and
- Product Approval and Launch
Join us to explore regulatory strategies for advancing new drugs to market from industry experts – Sharon Ayd, VP & Principal, Advarra Regulatory Center of Excellence and Anthony Waclawski, Former VP and Head, Regulatory and Pharmaceutical Sciences, CV, IS, Fibrosis and GDD at BMS. The webinar will dive into current regulatory challenges your teams face and recommend strategies to expedite go-to-market plans across multiple activities like planning, submissions, approvals, and more.
- Critically assess and gain in-depth understanding of evolving FDA regulations for US drug development and approval
- Understand the process for developing a new drug and how different functional areas interact with each other along the way
- Learn successful strategies for interacting with the FDA and achieving drug approval
VP & Principal, Regulatory Center of Excellence
Former Vice President and Head, Regulatory and Pharmaceutical Sciences at BMS
Who should watch?
This content applies to sponsors and CROs, growing biopharma and pharma companies - anyone involved in FDA-regulated research, Director of Regulatory Affairs, Clinical Trials Regulatory, Clinical Research, Regulatory Program Supervisor, VP Regulatory Affairs, Regulatory Scientists, Exec Director Regulatory Policy, and Intelligence, regulatory policy and intelligence analysts.
Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
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