Feature articles for July focused on managing regulatory information and systems and eCTD submissions.
The regulatory industry is being challenged by the increasing complexity and rate of change associated with compliance related requirements, while also focusing on improving the efficiency of operations across the enterprise. For regulatory professionals, effective management of information and content is critical to managing interactions with health authorities on a global basis. Emerging standards including IDMP and eCTD 4.0, will provide the industry with the opportunity to rethink how regulatory information is managed to both improve compliance and also support more cost effective operating capabilities. The July collection of articles focuses on preparing regulatory professionals to not only meet, but embrace these changes.
Here's a recap:
Brolund, Gens and Powell discuss a new World Class Regulatory Information Management (WCRIM) standard and current industry status in their article "Transformation Underway in how Regulatory Information is Globally Managed." Recent industry surveys have reported gradual increases in regulatory information capability (systems and processes) investment since 2007 with a dramatic leap over the past two years. Regulatory organizations are transforming how they work globally in an increasingly complex regulatory environment with the goal of improving efficiency and reducing costs.
In the article, "The Innovation Imperative for Biopharmaceutical Regulatory Science: Three Emerging Trends," Clay, Griffett and Outteridge discuss how manufacturers' regulatory affairs functions could improve their conduct of regulatory science through adaptive pathways, joint scientific and health technology assessment advice and patient-centricity.
Dowdley and Shemanski describe how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. "Accelerating Global Submissions with a Six-Point eCTD Strategy" outlines challenges specific to large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise.
The expanding role of regulatory operations is the focus of Gassman's article "How Technology Advances Have Equipped Operations Teams to Play a new Strategic Role." In it, he describes the expanding function regulatory operations plays within organizations and how their broader responsibilities as process engineers, RIM systems experts and business analysts will play an increasing role in the organization's success.
Shepley discusses the process and technology challenges regulatory operation organizations face as they seek to operate globally and provides recommendations for how they can begin addressing them in "The Path to Successful Global Regulatory Operations: Document Management Processes and Technology Challenges."
"eCTD: Journey Through the Decade" by Trivedi discusses transitioning and implementing the electronic Common Technical Document (eCTD) in different regions a decade after its conceptualization. The article further explores the impact on dossier compilation and document design practices as well as challenges faced by the pharmaceutical industry for effective lifecycle management.
We hope you find these articles informative as well as thought provoking. Please send any comments or questions to Gloria Hall at firstname.lastname@example.org. Your feedback is welcome.