Creating a Global Regulatory Plan

Instructor: Cheryl Wagoner
Product ID: 703283
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

Why Should You Attend:

How many of us have jumped into pursuing a new market before knowing the regulatory requirements and impact? If you have, you are not alone. Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.

This webinar will discuss generating and maintaining a global regulatory plan. Having and maintaining a strong global regulatory plan can help your business not only stay in compliance but can be an integral part of corporate marketing strategies.

Areas Covered in the Webinar:

  1. Describe the primary benefits of developing and maintaining an effective Global Regulatory Plan.
  2. Applicable Laws, Regulations, Guidance, Rules, and Standards in EU, Canada, and US.
  3. Elements of an effective Global Regulatory Plan.
  4. Interfacing: Roles and Benefits
  5. Alignment between Regulatory Plan/Strategy, Reimbursement, and IP
  6. Questions and Issues to Identify and Address

Who Will Benefit:

This webinar will provide valuable assistance to following personnel:

  • Regulatory managers
  • Project managers
  • Product development managers
  • Marketing managers
  • Staff involved with regulatory filings

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. Ms. Wagoner currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

She is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management. She also presented “Develop a Publication Strategy with KOLs during Clinical Development” at CBI’s 8th Annual Forum on Interactions with Thought Leaders and Key Opinion Leaders (KOLs) as well as served as a panelist for “Transparency Strategies and Their Impact on Relationships with Thought Leaders”.

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