News
The 505(b)(2) Forum to Feature Successful Methodologies and Technology Approaches
(North Bethesda, MD; Oct. 14, 2014) – The 505(b)(2) Forum, organized by thought leaders from four leading product developers and outsourced service providers, is scheduled for Oct. 27 during the Generic Pharmaceutical Association (GPhA) Fall Technical ConferenceinNorth Bethesda, MD.
“The 505(b)(2) Forum is an opportunity to educate and learn from others about this regulatory approval pathway,” said Ken Phelps, president and CEO of Camargo Pharmaceutical Services. “A collective assembly of product developers and service providers will share their experiences and expertise to help improve best practices across the 505(b)(2) development process.”
This exclusive presentation is scheduled for Monday, Oct. 27, at 6:30 p.m. EDT, during the GPhA Fall Technical Conference. A series of case studies will be reviewed to demonstrate proven methodologies for identifying and developing 505(b)(2) candidates.
“This forum provides an excellent opportunity to discuss key considerations and technology options for 505(b)(2) product concepts,” added James Coward, global head, marketing and market development, Capsugel Dosage Form Solutions.
“To achieve success with the 505(b)(2) approval pathway, developers need to understand how to evaluate potential benefits and challenges. We’ll identify some of the key challenges and approaches we’ve applied to reduce time,” said Mic Iwashima, global research and development, global business development, SNBL, Nasal Delivery System Division.
“The 505(b)(2) approval pathway can offer a streamlined route to market if a developer understands the process,” said Marc Lefebvre, vice president of scientific affairs, Algorithme Pharma. “Our goal will be to help attendees pave the way to more efficient product development.”
Learn more about the event at 505b2forum.com.
About the 505(b)(2) Forum
The 505(b)(2) Forum was organized by product developers and service providers interested in improving best practices across the 505(b)(2) development process. From candidate identification and CMC, to shaping regulatory and commercial strategies, participating companies and attendees will discuss the 505(b)(2) regulatory approval pathway and supportive technologies for successful product development. Representative case studies will be reviewed to demonstrate proven methodologies for identifying and developing viable 505(b)(2) candidates.