Feature articles over the past weeks covered strategies for regulatory intelligence communication and management, the need for quality, relevant and timely intelligence and the importance of regulatory intelligence when preparing for meetings with FDA and other global regulators. Articles also covered emerging trends in risk management, risk evaluation and mitigation strategy and the changing landscape of drug promotion.
To stay current with the rapidly changing landscape, regulatory professionals must monitor and identify pertinent regulatory information on a continual basis. This information must be analyzed and interpreted for the application and implications to team projects, the organization and potentially other partners or clients. But generating this intelligence is just the first step. In their article, “Proactive Regulatory Intelligence Communication
,” regulatory experts Emily Huddle
and Kirsten Messmer
identify communication approaches for medium to large companies and highlight the advantages and disadvantages of each.
Scientific advice allows health authorities to support the development of high quality, effective and safe medicines to meet patients’ needs and it is critical for companies to properly understand and optimize their use of scientific advice procedures. Regulatory consultant Amy Hughes
discusses the various options available to companies when requesting scientific advice to assist with the development of their product in “European Scientific Advice Procedures
Regulatory Intelligence (RI), in one form or another, has always been a component in a successful FDA meeting. However, in past years, as specialization of functional areas has continued to fracture and diverge, the need for quality, relevant and timely RI has increased. Regulatory manager Matt Medlin
illustrates how to best leverage a dedicated RI function or skill set to prepare for and have the most successful regulatory interaction with FDA. “FDA Meetings: The Application of Regulatory Intelligence in Preparation and Execution
” provides insight and suggestions regarding the role RI professionals can play to help assure a successful interaction during each FDA meeting phase.
How do you keep track of everything, read everything and know how to get regulatory intelligence? Regulatory and quality expert Richard Vincins
addresses this question and more in “Managing Regulatory Intelligence for Medical Devices
.” He covers how medical device guidance documents, regulations, standards and requirements are presented in increasing amounts and how regulatory professionals can access, assess, manage and ultimately report to their organizations on the potential impact of regulatory changes. He includes “tips” for making the hard work of international regulatory intelligence for medical devices easier and more efficient.
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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