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Regulatory Differences Between Biopharmaceutics and Medical Devices

ComplianceOnline

Thursday, August 8, 2013 from 10:00 AM to 11:00 AM (PDT)

Regulatory Differences Between Biopharmaceutics and Medical ...

Ticket Information

Ticket Type Remaining Sales End Price Fee Quantity
Single Registration 20 Tickets Ended $249.00 $14.69
Group Registrations 20 Tickets Ended $999.00 $39.92
OnDemand Registrations 20 Tickets Ended $299.00 $17.44
Registrations for CD 20 Tickets Ended $499.00 $24.92

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Event Details

This webinar will review the similarities and differences in the regulatory paths and requirements for drugs, biologics and medical devices. It will discuss the applicable FDA “Centers,” the IDE and IND process, as well as 510k, PMA, NDA and BLA submission processes.

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?

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 510k 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.

Learning Objective:

At the end of this webinar, participants will understand regulatory similarities and differences between drugs, biologics, and devices.

Areas Covered in the Webinar:

  • 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?


For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703020?channel=Eventbrite

Have questions about Regulatory Differences Between Biopharmaceutics and Medical Devices? Contact ComplianceOnline

When

Thursday, August 8, 2013 from 10:00 AM to 11:00 AM (PDT)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on :

 

  • Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
  • Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
  • Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
  • Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

 

 

 

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