The field of combination products, a significant area of the US Food and Drug Administration (FDA), is rapidly evolving, and eliciting increasing interest worldwide. Combination products employ a multi-faceted treatment approach with devices, drugs and biologics. The US Food and Drug Administrations (FDA) Office of Combination Products focuses on formulating regulations and guidance documents. EU regulations have some similarities to and some differences from FDA’s approach to combination products. International developers could encounter challenges during the product development and clinical evaluation of these products due to the lack of globally harmonized regulations.
This webcast will provide a comprehensive overview on the current status of regulations, challenges and future trends in the US, Europe and emerging markets.
Learning Level(s): Intermediate & Advanced
Upon the webcast's conclusion, you should:
- Be knowledgeable about current and developing US and EU regulations
- Be apprised of the broad applicability of combination products and device software to high-profile disease targets
- Understand the scope and potential of these products in the US and emerging markets
- Be able to make informed decisions and provide accurate recommendations to management on corporate development strategies for these products
Who Should Attend:
- Product development professionals
- Regulatory professionals
- QA/ QC professionals
- Business development professionals
- Software developers whose software may be considered a medical device
- University Technology Transfer Officers
Chitra Edwin, PhD, president, Biotechnology Consulting Solutions Ltd.
Chitra Edwin is currently a consultant and president of Biotechnology Consulting Solutions Ltd., founded in 2006. She has significant product development and management experience in biotechnology, device and IVD companies. Edwin has been a key member in the development of products for HIV and cancer that have gained regulatory approval. She has successfully established and managed GLP and CLIA compliant laboratories, and led collaborations between national and international professionals. She has been a facilitator between academia and the bioscience industry. She is an adjunct associate professor of pharmaceutical sciences, and director of the Capstone project, College of Pharmacy, University of Cincinnati. Edwin holds a PhD. in medical microbiology/immunology from the University of Minnesota, and has completed post-doctoral training in infectious diseases at the Harvard Medical School, and the Dana Farber Cancer Institute. She has earned the RAC US certification. Edwin is also is a board member of Opus Institutional Review Board (IRB).
Jane Green, PhD, CEO, The Morley Research Consortium
Jane Green is currently CEO of The Morley Research Consortium in Atlanta, GA. She was instrumental in setting up the first community-based research program in an outpatient setting. She developed the first oncology-based network for clinical research. Green was nationally recognized by NSABP for having one of the top five research programs in the nation for two consecutive years. She was one of the original board members and founders of SoCRA (Society of Clinical Research Associates). She is a published author, and has been a national speaker and trainer for many years. Green holds an MS and PhD in natural science from Clayton College. Before entering the life sciences industry, Green was an FBI agent and spent eight years in law enforcement.