Creating a Global Regulatory Plan
Instructor:
Cheryl Wagoner
Product ID: 703283
- Duration: 60 Min
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:
- Describe the primary benefits of developing and maintaining an effective Global Regulatory Plan.
- Applicable Laws, Regulations, Guidance, Rules, and Standards in EU, Canada, and US.
- Elements of an effective Global Regulatory Plan.
- Interfacing: Roles and Benefits
- Alignment between Regulatory Plan/Strategy, Reimbursement, and IP
- 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
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”.
More Training By Experts
- Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance
- Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)
- How to file a 510(k) when your device is (or contains) software
- Is your Essential Requirements Checklist (ERC) up to snuff?
- Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
