Webinar: Preparing for the Physician Payment Sunshine Implementation: Research, Marketing & Education ~ Apr 29

Newly Released Webinar:

Preparing for the Physician Payment Sunshine Implementation:
Research, Marketing & Education
April 29 | 1:00-2:30 PM ET

All transfers of value to covered recipients must be tracked by covered manufacturers starting August 1. This 90-minute webinar will provide a high-level overview of the basic requirements of the final rule for implementing the Physicians Payment Sunshine Act, before turning to many of the gray areas where manufacturers are struggling to understand what they need to track and report. This webinar will focus on the requirements for research-related activities, indirect payments, and the determination of value for many educational efforts. Industry experts will help you go beyond a cursory understanding of the rule to help their organizations determine how they will ensure compliance and avoid the costly fines.

  Overview | Register Online

Featured Webinar: Off-label Marketing Regulation in the Wake of the US v. Caronia Decision

Examine Industry Implications and Impacts of the Recent Federal Appeals Court Decision Featured Webinar: Off-label Marketing Regulation in the Wake of the US v. Caronia DecisionJanuary 23 | 11:00AM-12:30PM ET On December 3, 2012, the United States Court of Appeals for the Second Circuit issued its decision on United States v. Caronia, which may reset the legal boundaries between the FDA and pharmaceutical manufacturers’ rights to disseminate off-label information about approved drug products. While the full impact of Caronia remains to be seen, this 90-minute webinar will explore the dimensions of the conversations and decision on off-label marketing regulation that will occur in the coming months and years. In This Webinar You Will: • Examine the US v. Caronia decision • Discuss possible appeals • Explore potential impacts on "false claims" acts prosecutions and settlements • Discuss the implications for the industry • Evaluate the impact on off-label marketing regulation, including social media Overview | Register Online Effectively Market Your Products in Highly Regulated Environments Marketing Pharmaceuticals 2013 February 19-21 | Washington, DC It's not getting any easier to understand or be in compliance with all the various regulatory and legal requirements that apply to marketing and promoting pharmaceuticals, over-the-counter (OTC) drugs, biologics, and medical devices. With the impending implementation of the Affordable Care Act and PDUFA V/FDASIA even more change is coming, and how drug and device manufacturers market their products will continue to evolve. Don't be caught unprepared. Register Online by January 30 to Save $150 A Forum for Medical Communication, Medical Information, Medical Science Liaison, and Medical Writing Professionals Medical and Scientific Communications 2013 Annual Forum March 18-21 | Chandler, AZ In its 24th year, we have expanded the content of this annual forum to meet the needs of those who work in pharmaceutical based medical and scientific communications by including three separate tracks covering: • Medical Communications • Medical Writing Regulatory and Publication • NEW THIS YEAR! Medical Science Liaisons Register Online by February 25 to Save $150!

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PCORI "Transforming Patient-Centered Research: Building Partnerships and Promising Models," October 27-28

PCORI - Oct 26, 2012 The Patient-Centered Outcomes Research Institute (PCORI) is providing a free webcast for the plenary sessions of its patient engagement workshop, "Transforming Patient-Centered Research: Building Partnerships and Promising Models," October 27-28. The workshop is designed to help PCORI build a patient-centered research community.   Workshop participants will help PCORI establish procedures for identifying research questions, reviewing research proposals for funding, and ensuring patient participation throughout the research process. It is the first in a series of workshops aimed at bringing PCORI's vision for patient and stakeholder engagement to life.   Because in-person attendance at the workshop is limited and full, following an open application process, PCORI is providing three opportunities for all patients and healthcare community members to be a part of the process and provide input on the workshop's five topics: Identifying and Selecting Research Questions Reviewing Research Proposals for Funding Matching Patients and Stakeholders with Researchers Disseminating Research to the Community Evaluating PCORI's Patient and Stakeholder Engagement Programs   To take part, you can: Watch a live webcast of workshop plenary sessions: Saturday, October 27, 8:30 a.m.-11:00 a.m. ET Sunday, October 28, 8:00 a.m.-12:30 p.m. ET Join the conversation on Twitter by following @PCORI and using the #PCORI hashtag during the workshop. Provide feedback to PCORI on the workshop topics by email to GetInvolved@pcori.org. Feedback received will be considered as PCORI develops a report on the workshop.   Visit pcori.org to access the webcast, view the workshop agenda, read more about the workshop topics and get to know our presenters and facilitators. We look forward to your participation and feedback as we build a patient-centered research community. Patient-Centered Outcomes Research Institute | 1828 L Street, NW | Suite 900 | Washington | DC | 20036

 

Updates on Regulatory Developments and Guidances on Drug/Device Combinations and Companion Diagnostics ~ Premarket Considerations

Learn the Regulatory Processes for All Aspects of Product Development and Management Combination Product Premarket Considerations May 21 | 11:00AM-12:30PM ET FDA receives a large number of combination products for review as technological advances continue to merge product types. Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they often raise difficult policy, regulatory, and review management challenges. This 90-minute webinar will cover topics from what kind of product you have, to how it’s assigned, to application development and review, as well as the premarket steps for combination products. Case studies and scenarios will bring these steps together. Presenters: • Kathy Lee, Lead Interdisciplinary Scientist; Division of Therapeutic Proteins/OBP/OPS/CDER, FDA • Hina M. Pinto, Regulatory Advisor, CDRH, FDA Who Should Attend? Pharmaceutical, academic and government senior-level professionals and decision-makers involved in: • Drug Research and Development • Medical Device and Diagnostics • Regulatory Affairs • Clinical Research • Development of Drug/Device Combinations and Companion Diagnostics Overview | Register Online Next Week's Webinar: A Closer Look at FDASIA Provisions to Promote Biomedical Innovation April 30 | 12:30-2:00PM ET The Food and Drug Administration Safety and Innovation Act (FDASIA) includes a number of significant new provisions to promote the development and availability of safe, effective, and innovative therapies. This webinar will discuss these provisions as well as the user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilars. Overview | Register Online May 23 | 10:00AM-12:00PM ET May 30 | 1:00-2:30PM ET Almost Half of the Sites Recruited by Trial Planners End up Enrolling Less than Two Patients Connecting the Right Sites to Promising Trials: The Role of Web-based Feasibility Assessment May 22 | 10:00-11:30AM ET Selection of the right sites for a promising clinical trial is the most relevant step in the planning process for subsequent successful study conduct. A number of obstacles stand in the way of efficient implementation of this process. This webinar will address common weaknesses in the established process of feasibility assessments and site selection, from the point of view of both trial planners and research centers. You will learn relevant key performance indicators (KPIs) and how to address them, global country selection strategies, and better management of site feasibility assessment by improving the efficiency of information exchange between sites and trial planners. Overview | Register Online Stay Up-To-Date with DIA

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