Gretchen Bowker
Instructor Gretchen Bowker
Product Id 601230
Duration 60 Minutes  
Version Recorded
Original Price $300
Special Offer Price $15
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Biopharmaceutics vs. Medical Devices: Similarities and Differences in the FDA Regulatory Paths


Why are FDA regulatory submission requirements so different for biopharmaceuticals and devices? This webinar will review FDA regulatory requirements for approval of drugs and biologics and the clearance of medical devices. You will gain an understanding of the Centers for Drugs (CDER), Devices (CDRH), and Biologics (CBER), their requirements for clinical research (IND vs. IDE), as well as the path for approval or clearance to sell product in the US.

You will learn about the path for 501k clearance or PMA (pre market approval) for devices, and NDA (new drug applications) and BLA (biologics license applications) for biopharma products. Combination product regulations will also be reviewed.

Why should you attend: Do you currently have responsibility in the regulatory group for drugs but want to learn more about devices or vice versa? Are you confused by all the FDA Centers and want to know the applicable FDA division for your technology? Are you launching a drug-device combination product and need to map out a parallel regulatory path? Would you like to do a clinical research study utilizing a non-approved drug or biologic? Do you want to know if a device meets the category for IDE exemption? If yes, you should consider attending this one-hour webinar which will educate you on the similarities and differences in the regulatory paths and requirements for these products.

This session will review FDA regulatory requirements, the applicable FDA “Centers,” the IDE and IND process, as well as 510k, PMA, NDA and BLA submission processes

Areas Covered in the Session:

  • Review of FDA regulations for biopharma vs. devices
  • FDA Centers: CDER, CBER, CDRH
  • What if the product is a combination product…which do I lead with?
  • What is the difference between the requirements for an IND vs. IDE?
  • What are the requirements for a 510k (class I and II) and PMA submissions?
  • What is needed for NDA and BLA submissions?

Who Will Benefit:
  • Companies who sell, distribute or manufacturer drugs, devices, biologics, or combination products
  • CRO Personnel who are involved in regulatory submissions
  • Contract Manufacturers who provide regulatory submission data for their clients
  • Regulatory Professionals

Speaker Profile
Gretchen Bowker serves as Chief Operating Officer for Pearl Pathways and has over 25 years experience in the development of drugs, biologics and devices. She is a recognized leader in regulatory, bioethics, and compliance. She has extensive experience in working in an academic research setting, large pharmaceutical companies, small biotechs, and large device companies. Gretchen spent over 15 years of her career in large sponsor company environments working at both Eli Lilly and Roche Diagnostics (formerly Boehringer Mannheim). She also has real world small start up experience having led the regulatory, quality compliance and clinical teams at a small biotech startup. Throughout her career, she has successfully assembled teams of experts, driven organizational growth, developed processes and procedures, and implemented strategic plans, which ensured successful product development of drug, device and diagnostic products.

Prior to co-founding Pearl Pathways, Gretchen served as Director of Regulatory and Compliance Service Delivery at a Midwest consulting company where she served institutions, sponsors, and CROs. Gretchen is an experienced team leader with specific expertise in meeting global regulatory body expectations, clinical development, and regulatory compliance. At Pearl Pathways Gretchen oversees the company’s commercial IRB Board, oversees all client consulting engagements, and serves as the company’s Quality Director.

Gretchen has lent her talents as a guest speaker on quality and regulatory topics for Indiana University, Purdue University and multiple national healthcare and pharmaceutical conferences, and is the current Chair of the Indiana Chapter of RAPS. She has held the position of Adjunct Professor of Clinical Research and Regulatory at The George Washington Medical School. She also serves as the Chair of the Indiana RAPS Chapter and is on the Indiana Health Industry Forum’s Clinical Trials Alliance. Gretchen earned an M.S. in Biology from Purdue University, a B.S. in Biology from Indiana University, and has been RAC certified since 2002 and a RAPS fellow since 2011.

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