Webinar on FDA Expectations from 505(b)(2) Product Development Pathway

Compliance Trainings, Online
2016-04-12

This seminar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.

Areas Covered in the Session :

The 505(B)(2) regulation and guidance from the FDA

Strategic considerations before embarking on a 505(b)(2) development project

Intellectual property issues with such products

Key development steps for such products

FDA’s review process and ongoing consultation

Challenges to developing 505(b)(2) product and possible solutions

Examples of successful strategies for developing such products

Searching for a 505(b)(2) project, future trends

505(b)(2) and biosimilars

Speaker's PASS-IT Recommendations

Who Will Benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

Research & Development

Project Managers

Consultants

Contractors/Subcontractors

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA's transparency public meeting in 2009.

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