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New York/New Jersey Chapter Webcast: Conducting a Clinical Trial Amidst the COVID-19 Pandemic

Learn from two industry experts as they breakdown the best practices on the US Food and Drug Administration’s (FDA) recent Guidance on Conduct of Clinical Trials of Medical Products during COVID-19.
COVID-19 Member Knowledge Center fda Clinical trials
On Demand Webcast
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(On-Demand Webcast) The Exciting Journey of Machine Translation Deployment in the Life Science Industry

Join us for a webcast to learn how best practices can leverage NMT and AI in a highly regulated industry.
technology management project management innovative pharma reg info management clinical trials/design/management/reporting
On Demand Webcast
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Negotiation is Another Word for Problem Solving (On-demand Webcast)

Improve your negotiation skills in this webcast by learning to probe the interests of the other party, acknowledge feelings, listen actively, ask revealing questions, seek options for mutual gain and understand that the most powerful interests are basic human needs.
business strategy Negotiations government affairs Communications
On Demand Webcast
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Together We Are Stronger —Building an Enterprise-Wide Strategy for Risk (On-demand Webcast)

This webcast will teach you how leaders across the industry are driving regulatory professionals towards creation of one simple, aligned strategy for risk that aligns all of an organization’s risk functions.
medical devices otc drugs innovative pharma biologics generic drugs
Webcast
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Giving Voice to Regulatory Leadership (On-demand Webcast)

Learn the professional development skills you need for success, including how to advance these critical skills and how to improve the power of your regulatory voices strategically.
business and leadership
On Demand Webcast
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Best Practices for Building An Efficient Literature Review Process (On-Demand Webcast)

This webinar provides valuable information to help manage the dramatically increased workload as a result of the new EU MDR.
medical devices packaging project management labeling writing Risk Management advertising and promotion compliance
On Demand Webcast
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China NMPA and US FDA Emergency Approval and Implications to Life Science Companies Relating to COVID-19 (On-Demand Webcast)

Learn about China NMPA's response to the COVID-19 pandemic.
medical devices drugs quality manufacturing compliance biologics IVD
On Demand Webcast
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PMS Requirements of the EU MDR: Implementation Challenges and Solutions (On-Demand Webcast)

We have a choice: Continue to apply Band-aids to our PMS processes and procedures, or think long-term and get it right for good. We're sharing several real examples that have worked and know what the notified bodies actually want to see.
medical devices postmarket surveillance regulatory strategy Risk Management postmarket compliance
On Demand Webcast
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Strategic Role of the RA Professional (On-Demand Webcast)

Learn how you can positively impact your cross functional team interactions and potentially bring new products to market faster. Presented by RA professionals who have experience in premarket through post market activities.
medical devices project management career development regulatory strategy Communications R&D
On Demand Webcast
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EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe (On-Demand Webcast)

Medical device regulatory experts will provide insights about how the current language requirements will change with the MDR. Experts will cover highlights of the major changes with the EU MDR, and the MDR’s specific requirements for translation.
project management labeling regulatory strategy writing Quality Assurance compliance
Webcast
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21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices (On-demand Webcast)

The RAPS Philadelphia Chapter webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.
Quality Compliance and Risk medical device
Webcast
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Regulatory Intelligence and Its Value in Regulated Industry (On-demand)

The webcast will include the fundamentals of global regulatory intelligence, and how it can be used to influence regulatory decision making throughout a development program and lifecycle management of a therapeutic product.
regulatory intelligence
On Demand Webcast
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How to Facilitate Regulatory Meetings (On-demand Webcast)

This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation. Learn to effectively facilitate teams as they prepare for, conduct, and debrief important meetings
government affairs Communications
On Demand Webcast
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What You Need to Know About FDA Regulation of Medical Product Promotional Labeling (On-demand Webcast)

This webcast will provide an overview of the book content and discuss considerations for implementing quality systems and procedures that will help you remain in compliance with promotional labeling regulations.
medical device advertising and promotion
Webcast
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How to Better Manage Quality and Risk with a Global Change Control Strategy (On-demand Webcast)

Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.
Quality Compliance and Risk
Webcast
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Overview of China's Regulatory System & New Medical Device Regulations (On-demand Webcast)

What is the new regulatory system in China? What are the new regulations? What are the major changes? What are the key challenges for the industry? The webcast introduces the overall new regulatory system and outlines the regulatory framework in China.
asia medical device
Webcast
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The Supervision of Medical Device Label and Instruction for Use in China (On-demand Webcast)

Learn more about the medical device lifecycle in China.
asia medical device
Webcast
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A Roadmap for Driving Messages through Development, Submission and Beyond (On-demand Webcast)

Learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
business and leadership regulatory strategy
Webcast
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Understanding and Applying FDA’s 510(k) Modifications Guidance (On-demand Webcast)

FDA’s guidance on when to submit a 510(k) for a changed device is significant and wide-ranging in its impact. This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
medical device
Webcast
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Webcast: The Art and Science of Regulatory Intelligence: What You Don't Know Can Hurt You

You will be able to understand the art and science behind regulatory intelligence and why regulatory intelligence is vital to your success and your organization.
quality regulatory intelligence regulatory strategy compliance