Regulatory Landscape of Complex Drug Products*
*Additional registration, payment, and ticket required.
Saturday, July 16, 2016 • 8:30 a.m. – 5:00 p.m.—Room 608-609
About the Workshop
Complex drug products have provided entirely new ways for treating various diseases including cancers, rheumatoid arthritis, and so on. Complex drug products can vary from biologics, peptides, RNA to complex drug delivery systems. Their complex nature presents unique challenges for regulatory evaluation. This workshop will discuss the special characteristics of complex drug products covering aspects specific to their manufacturing, nonclinical, and clinical development and summarize the challenges associated with regulatory evaluation in the United States, European Union, and Japan.
Goals and Objectives of the Workshop
This workshop is beneficial for professionals from pharmaceutical industries and academia who work with complex drug products and those interested in understanding the basics of regulations in the United States, European Union, and Japan.
Invited Speakers and Topics
*invited speakers and topics subject to change
|8:30 - 8:40 a.m.
||Hong Wen and Yan Wang, FDA
||Welcome and Introductions|
|8:40 - 9:20 a.m.
||John Petricciani, IABS
||International Regulatory Landscape for Human Cell Therapy|
|9:20 - 10:00 a.m.
||Serge Beaucage, FDA
Amphipathic trans-Acting Phosphorothioate DNA Elements Delivery Uncharged PNA and PMO Nucleic Acid Sequences in Mammalian Cells
|10:00 - 10:15 a.m.
|10:15 - 10:55 a.m.
||Mohan Sapru, FDA
||Oligonucleotide Based Therapeutics|
|10:55 - 11:35 a.m.
||Audrey Jia, Consultant
||Regulatory and Quality Considerations in Developing Biosimilar Products|
|11:35 a.m. - 12:00 p.m.
||Panel Discussion with Speakers|
|12:00 - 1:00 p.m.
|1:00 - 1:40 p.m.
||Evangelos Kotzagiorgis, European Medicines Agency
||EMA Guidelines for Development of Biosimilars|
|1:40 - 2:20 p.m.
||Xiaohui Jiang, FDA
||Regulatory Considerations for Complex Drug Substances Including Peptides|
|2:20 - 3:00 p.m.
||Harsh Jain, FDA
||Amphipathic Trans-Acting Phosphorothioate DNA Elements Delivery Negatively Charged DNA and RNA Sequences in Mammalian Cells|
|3:00 - 3:15 p.m.
|3:15 - 4:00 p.m.
||Yan Wang and Wen Qu, FDA
||Implants and Parenteral Microspheres|
|4:00 - 5:00 p.m.
||Panel Discussion with Speakers |