Developing an Efficient Relationship with the FDA

This training will help attendees understand the process of developing a drug product and data necessary for approval. It will focus on relevant structure of the FDA, process of contacting the FDA, important milestone meetings and documents, how to resolve potential issues, and logistics.

Why Should You Attend:

The FDA and other regulatory agencies produce numerous guidance documents on specific topics that are very helpful. However, there are other issues that can interfere with the developmental process.

This webinar will identify these potential problems and recommend how to address them. Approaches to preparing a development plan will be addressed along with preparing individual documents (e.g. protocols, clinical reports, IND, NDA) that will provide the data necessary for approval. This webinar will be “required reading” for those who want to be a member of a drug project team and any of the sub-teams.

Areas Covered in the Webinar:

• Organization of the FDA
• Important meetings with the FDA
• Important stages in drug development
• Logistics of regulatory meetings
• Content of protocols and clinical reports
• Outline of IND and NDA application

Who Will Benefit:

This webinar will benefit individuals who are promoted to drug project teams and sub teams of the project team. Clinical research organizations who work with pharmaceutical companies to develop a drug product will also benefit. Following personnel will benefit from the course:

• Quality, regulatory and compliance professionals
• Production, manufacturing, design professionals
• Document control and record retention specialists
• Project managers, marketing professionals
• Clinical research professionals, study coordinators
• New doctors, medical directors, scientists and health care workers

Instructor Profile:

Robert L. Kunka, Ph. D. is an accomplished and respected scientist who contributed to the development of 28 approved pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submissions with successful clinical strategies, sound matrix management of individual study teams, and effective interactions with regulatory agencies leading to successful IND, aNDA, and NDA approvals.