FDA Marketing and Promotion Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will provide practical information on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. It will explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side, the course will detail the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints. This webinar will minimize the use of regulatory language and easily illustrate how participants can implement an effective and unified system. As an added bonus, the webinar will include information on the UDI rule and the eMDR rule.

This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

The webinar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. The presentation will to familiarize you with the current FDA rules and help you plan for developments expected in the near future.

This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes.

This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive knowledge on creation, approval and control of labels and labeling.

This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.

This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

This social media compliance training for healthcare companies will cover the legal and regulatory requirements governing the use of social media. A scenario-based learning approach will be used to show how to create a successful social media team by selecting members from relevant stakeholders, and prepare social medial policies and procedures.

This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.

This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.

This 120-minute webinar will cover the new (Federal) Physician Payment Sunshine Act, the topics raised by the proposed rule and existing State sunshine laws. Attendees will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to the relevant authority.

This 90-minute webinar will review FDA expectations/ requirements for discussing off label uses of medical products on social media, e.g.,Twitter®, Facebook®, etc. We will also discuss key elements of the FDA's new Draft Guidance, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices", Dec 2011.

This FDA Pre-Approval Inspection training will focus on the purpose and scope of pre-approval inspections, the consequences from them, and keys to a successful FDA pre-approval inspection.

This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.

This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

Learn the appropriate and expected regulatory strategies and guidelines for your IDE. This webinar will provide valuable assistance and guidance to medical device firms that are currently preparing or will prepare for IDE submissions.

This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.