Successfully advancing new drugs and life-saving therapies to market for emerging pharma and biotech organizations is an elongated process, involving complex challenges throughout product development. For these companies, the first major inflection point is the start of a Phase I clinical study.

A proactive, cross-functional, and risk-based early development plan is critical to a successful journey. This plan outlines the initial regulatory pathway, and contains details on the clinical trial design, and information on how and where the investigational product (IP) is manufactured. Building the investigational new drug (IND) requires compliance with many regulations. It also informs the Food and Drug Administration (FDA) on the translation from non-clinical pharmacology/toxicology work to justify the starting point for First-In-Human (FIH) studies.

Join us for a comprehensive guide through Phase I of the IND journey. Explore the latest strategies for advancing IND submissions. The webinar will dive into current IND submission challenges and recommend strategies for early-stage biopharma companies to achieve a successful outcome from their first pre-IND meeting with the FDA.

• Gain an in-depth understanding of the IND process
• Learn successful strategies for a pre-IND meeting
• Understand how to identify chemistry, manufacturing, and controls (CMC) risk factors
• Understand the importance of developing a clinical development plan

• Presenters
• CE Credits
• Certificate of Attendance

Sharon Ayd

Ph.D., MBA

Vice President & Principal, Advarra Consulting

Leslie Paul

Director, Quality Center of Excellence, Advarra Consulting

Attendance at this program 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.

There is no longer a survey component to the webinar. After watching this webinar in its entirety, 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.