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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The term digital health solution is used to categorize technology available through a multitude of devices which provide information to their end user, aimed at improving healthcare and outcomes. Enya Guo and Jessica Hale, et. al., discuss the challenges and opportunities within the digital health technology postmarketing safety and surveillance arena faced by many manufactures. “Postmarket Surveillance in a Digital Health Solution World: Challenges and Opportunities for an Evolving Industry”
presents the opportunities and challenges of these devices and technologies compared to the traditional healthcare products in the regulated arena.
The past decade has witnessed a major advance in the availability of medicinal products for pediatric patients including the pivotal European Union (EU) Paediatric Regulation which spurred an upsurge in the development of new medicines specifically intended for use in pediatric patients. Risk management experts Meredith Smith and Eric Ng describe recent additions to the EMA’s pediatric risk management toolbox in “Emerging Trends in Risk Management for Pediatric Patients.” They explore the pragmatic implications of these developments for industry and discuss the future evolution of risk management in supporting the safe and appropriate use of medicinal products in children.
Even though a drug’s professional labeling is the typical method for communicating safety information about a drug product, FDA can require a drug manufacturer to use Risk Evaluation and Mitigation Strategy (REMS) beyond the professional labeling to ensure the benefits of certain prescription drugs outweigh their risks. In “The Enforcement of Risk Evaluation and Mitigation Strategy (REMS),” legal expert Anne Walsh describes the evolution of REMS from a safety program to an enforcement tool and provides tips on how to minimize risk for drugs subject to REMS.
Promotional regulations for the sales and marketing of pharmaceuticals were established in 1962 with the passage of the Kefauver-Harris Amendment, also called the Drug Efficacy Amendment. Today, new technologies and new digital communication platforms used for drug promotion demand change.
In “The Changing Landscape of Drug Promotion in a Digital World and What it Means for Regulatory Reviewers,” regulatory expert Ilze Antons discusses the changing landscape of drug promotion and what relevant technological communication changes, such as the Internet and social media, may mean for regulatory reviewers. The author focuses both on the healthcare professionals who are demanding quick and easy methods of getting the latest pharmaceutical product information via digital media and how pharmaceutical sales and marketing teams are addressing using the Internet and digital communication to present product information.
What’s Ahead in February
Feature articles in February will cover the new FDA guidance related to oncology drug development, overseas inspections of drugs and medical devices, medical device software, more on regulatory intelligence communication and the role of artificial intelligence in supply chain security. February will also feature risk management and quality issues with the release of the Q1 Article Series: Risk Management Principles: A Global Perspective.
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