The regulatory strategy for the combination product is critical for guiding activities from development through lifecycle management of combination products. This presentation focuses primarily on the development and refinement of the regulatory strategy and submission planning and execution for drug Primary Mode of Action (PMOA) combination products, which combine a drug or biological product with a medical device. Many of the concepts discussed can also be applied to device PMOA combination products and to drug-biologic combination products. 

Regulatory inspections are crucial to maintaining compliance within regulated industries, especially in the life sciences industry. Given the high stakes of these inspections, organizations must remain compliant. 

Developing medical devices can be challenging, confusing, rewarding, and enjoyable all at the same time. Enjoy this free event to learn from industry leaders about demystifying the challenges of medical device development from generating the plan to submission to Regulatory Agencies.

Senior staff from Gad Consulting Services will provide details of the regulatory requirements, followed by multiple case studies to help understand requirements, challenges, solutions, and reporting from Study Management at PSL.

Join the Building Better Regions Community of Practice and New Growth Innovation Network on April 22 to launch the new Insight Report on Inclusive Cluster Development.

A new report by the Building Better Regions Community of Practice and the New Growth Innovation Network gathers evidence to answer the question, “How can we ensure the outcomes of cluster development initiatives benefit regions and people who have historically been excluded from economic opportunities?”

Exploring Sustainable Solutions
The SAFTS workshop, led by North Carolina State University, aims to deepen our understanding of “sustainability” in food systems. Through a multi-stakeholder approach, the summit will bring together scientists, industry experts, advocates, and policymakers to explore diverse perspectives on sustainability, share real-world innovations, and identify collaborative opportunities for the future.

The program will highlight the New Technologies in Vaccines chapter in the Rx for Science Literacy curriculum manual (provided at no cost) and feature talks from Wake Forest School of Medicine researchers about why vaccines matter, current topics in vaccine research, clinical perspectives, and more.

About the Curriculum: