Premeeting Workshops

Regulatory Landscape of Complex Drug Products*

*Additional registration, payment, and ticket required.

 

 

Workshop Price

Regular: $400
Student/Postdoc: $200

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

  • To discuss the special characteristics of complex drug products covering aspects specific to their manufacturing, nonclinical, and clinical development.
  • To summarize the challenges associated with regulatory evaluation of complex drug products in the United States, European Union, and Japan.

Target Audience 

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. Break  
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. Lunch  
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.  Break
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

© Copyright Controlled Release Society  | Contact Us - Report a Bad Link