DIA's Monthly In Focus Newsletter: Regulatory Affairs

DIA Research Join the DIA Research Study on Defining Tolerability Concepts for Immuno-Oncology (I-O) Therapies

Calling all industry leaders! DIA is conducting an important research study that aims to enhance our understanding of tolerability concepts in the context of I-O therapies in selected cancers and pave the way for the development of tolerability PRO instrument(s). By participating in this study, you will contribute to the advancement of tolerability in I-O therapies and ensure that patient preference is incorporated into clinical decision-making.

If you are passionate about pushing boundaries and making a difference in cancer treatment, we invite you to join us in this groundbreaking research study. Read more information here .

DIA Initiatives Think Tank Workshop on “Regulatory System Innovation through Collaboration and Reliance” Read the Summary Report from the DIA Europe 2023 Pre-Conference Workshop

The COVID-19 pandemic has catalyzed increasing cooperation and collaboration amongst regulators and more frequent communication with applicants. Regulators piloted new ways of working to speed regulatory actions and increase regulatory collaboration, and focused available resources on important public health matters. As we are now moving into the post-pandemic phase, stakeholders have been evaluating which of the regulatory agilities should be implemented more permanently to support regulatory systems’ innovation.

Harmonization of requirements towards global standards allows sharing of appropriate information across agencies to facilitate national decision-making. This will support earlier access to life-saving medicines in international markets where submissions and regulatory approvals often lag behind mature countries. In addition, the speed of technology innovation is accelerating, and the regulatory workload is increasing. To address this increasing demand, some regulators are implementing regulatory reliance for different regulatory activities, such as marketing authorization applications, inspections, post-approval changes, pharmacovigilance, and registration sample testing. Transparency and trust are necessary to establish more collaboration between regulators, which will then facilitate the use of reliance.

At the margins of DIA Europe 2023, regulators from different regions and industry experts came together for a Workshop to discuss the practical aspects of collaboration and reliance.

Download Complete Report Here

Open Access Research from Therapeutic Innovation & Regulatory Science

• Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Direction This study provides a broad overview of how RWE has been contributing to regulatory decisions in China and proposes applications to further facilitate innovative drug evaluation and regulation. Read the complete article.

• Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications This study identifies gaps between regulatory recognition of innovative clinical trial designs and regulatory review/approval processes between reference and Latin American regulatory authorities. Read the complete article.

• Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future—An Industry View This review article gathers insights on experiences and challenges in the use of agilities related to regulatory assessment of initial marketing and post-approval change (PAC) applications, and product development/clinical trial processes during the early phases of the COVID-19 pandemic. Read the complete article.

Global Regulatory Perspectives from Global Forum

• Healthy People, Healthy Spaces, Healthy Caribbean Caribbean Regulatory System Programme Manager Rian Extavour shares the agency’s past, current state, and what it needs to continue to do to ensure the safety of healthcare products and the patients who use them in its jurisdiction. Read the complete article in English or Spanish.

• ?A Year’s Worth of Progress: Insights from the FDA Town Hall 2023 The past year’s accomplishments include efforts towards enhancing DE&I in clinical trials and exploring the roles of AI and DHTs on future horizons. Read the complete article.

• Podcast: Retiring TGA Head Maps Australia’s Post-Pandemic Future In early 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administration in Australia. "I think regulators have become a bit more comfortable in dealing with uncertainty. Uncertainty is the biggest challenge rather than benefit-risk,” he explains. Listen to this podcast.

• New Agency for the New Era: African Medicines Agency and the Evolution of Continental Regulatory Systems This report highlights the AMA’s important role in the evolution of regulatory systems across the African continent, plus its future structure and function, how to facilitate regulatory reliance, and perspectives on how the EMA can assist in establishing the AMA. Read the complete article.

DIA Americas Meetings (2023-2024)

• Canada Annual Meeting (November 7-8, 2023) Includes a regulatory track of interest to those involved in regulatory science.

• Regulatory Submissions, Information, and Document Management Forum (February 12-14, 2024) This meeting is of interest to those involved in regulatory science and contains the following tracks: Track 1: Building and Sustaining Successful RSIDM Foundations Track 2: Optimizing Processes and Procedures Track 3: Adopting Innovative Technologies Track 4: Achieving Regulatory Excellence

• 2024 Global Annual Meeting (June 16-20, 2024) This meeting features multiple tracks on topics of interest to those involved in regulatory science.

DIA Europe, Middle East, and Africa Meetings (2023-2024)

• DIA Innovating Clinical Trials in Europe (November 15-16, 2023, Virtual) This meeting is of interest to those involved in regulatory science in the field of RWE/AI/Data Science in the EU region.

• DIA-RAPS 2024 Combination Products in the EU Summit (January 30-31, 2024, Brussels) This meeting is of interest to those involved in regulatory science and in Combination Products (Drug-Device and Device-Drug) in the EU region.

• DIA Europe (March 12-14, 2024, Brussels) This meeting is of interest to all stakeholders involved or interested in regulatory science and contains multiple tracks.

On-Demand Course for Regulatory Affairs Professionals

The Drug Safety Regulatory Requirements eLearning module provides information about pharmacovigilance harmonization initiatives and regulatory requirements around the world. It covers the key US and EU regulations, the roles that ICH and CIOMS play in drug safety regulations, good clinical and pharmacovigilance practices, and standard operating procedures (SOPs) that support drug safety.

The module takes an average of 4 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program (6 modules) or Drug Safety eLearning Bundle (7 modules).

Learn More Now!

Join DIA’s Regulatory Affairs Community

As a leading organization in the field of Regulatory Affairs, DIA offers a unique platform for professionals like your to collaborate, network, and contribute to advancing clinical research and patient safety. By joining our Regulatory Affairs Community, you will have the opportunity to share your expertise, exchange ideas with industry experts, and shape best practices in this critical area.

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