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    Implementing Best Practices for Global Regulatory Intelligence Programs: Dos and Don'ts

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    Website https://compliance2go.com/product/?pid=CP2014-429 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: March 25, 2015 | Date: March 25, 2015

    Venue/Country: Online, U.S.A

    Updated: 2015-02-27 17:39:13 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This webinar is intended to help you get familiar with the best practices for global regulatory intelligence programs including dos and don’ts.

    This webinar is further intended to increase our awareness for the importance of implementing a holistic global regulatory intelligence program suitable for your medical product types.

    It is believed that actionable and practical regulatory intelligence can help an organization save a significant amount of resources (time, efforts and financial).

    Thus, it is imperative we become aware of and get familiar with the best practices for developing a global regulatory intelligence program.

    This webinar will address the best practices for you to take action, significantly benefiting your organization in many ways.

    Why Should you Attend

    To adequately develop and implement a holistic global regulatory intelligence program.

    Areas Covered in the Webinar

    Applicable Laws and Regulations

    Guidance, Rules, and Standards

    Regulatory Intelligence for Drugs, Biologics, Biosimilars, and Medical Devices including In Vitro Diagnostic Medical Devices (IVDs)

    What Is Important to Consider?

    R&D, Patenting (IP) and Applicable Regulatory Pathways

    Questions and Issues to Identify and Address

    Totality and Flexible Approaches

    Interfacing: Roles and Benefits

    Reimbursement Issues: What, When, Why, and How

    Intellectual Property (IP) Issues

    Alignment between Regulatory Plan/Strategy, Reimbursement, and IP

    New Requirements to Integrate: Risk Management Plan (RMP)/Pharmacovigilance (PV)

    FDA Unique Device Identification/Identifier (UDI)

    Detailed Contents

    Common Mistakes Leading to Serious Consequences (Patient Safety and Business Operations)

    Practical, Actionable, and Sustainable Solutions (PASS)

    Speaker’s Experience and Actual Cases

    Who will Benefit

    Regulatory Affairs

    Management: CEOs, VPs

    R&D and Product Development

    Legal Counsel and Compliance Officers

    Marketing

    Clinical Affairs

    Consultants

    Contractors/Subcontractors

    Other Interested Parties

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    Copy of PowerPoint slides (PDF print only)

    60 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.