AAPS Spring Workshops
March 9‒11, 2020
Sheraton Imperial Hotel Raleigh-Durham Airport
Research Triangle Park, N.C.
Early registration deadline is February 17, 2020.
Call for Papers deadline is January 13, 2020.
Development of parenteral formulations and processes is often multifaceted, as it has to address not only the characteristics of molecules but excipients, subsequent processing, and the primary container closure system. The degree of complexity increases if the product is intended to be filled into a syringe for lyophilization or used in a self-administration device. Throughout the development process, adequate characterization and controls are needed to assure both quality and sterility of the product is maintained and delivered to the patient.
With the recent excitement generated by gene, CAR-T, and other cell therapies, the use of sterile products has expanded and so have the difficulties in formulation, shipping, container closure integrity, and maintaining the viability of product at temperatures as low as -132°C.
The 2020 Arden House meeting will address current progress, lessons learned, and provide a forum for discussing new areas where there is a debate on the best approach to resolve the problem. Experts in the field of formulation, process, devices/combination products, aseptic risk assessment, and regulatory affairs will provide a unique learning forum for sharing experiences via case studies, practical examples, and success stories.
Learning Objectives
- Understand and provide practical solutions for the development of sterile drug products.
- Articulate the emerging areas of concerns (e.g., visual and subvisible particles, degradation of polysorbate), along with potential ways to address them.
- Recognize the regulatory expectations and good manufacturing requirements along with regional differences.
- Appreciate the complexity of container closure and device development, including integrity testing, extractables, and human-use studies.
- Become knowledgeable in formulation and process development with associated risks with aseptic processing, for example lyophilization, bioburden control, filtration,n and process simulation (media fill).
Register today!
April 20‒22, 2020
Hilton McLean Tysons Corner
McLean, Va.
Early registration deadline is March 30, 2020.
Call for Papers deadline is February 26, 2020.
The 2020 AAPS Drug Transporters Workshop will be the 10th workshop in the long-standing series Drug Transporters in ADME: From the Bench to the Bedside. The overall goal of the workshop is to bring together world leaders in the transporter field from academia, industry, and regulatory agencies to enhance interaction and communication between these three entities.
Learning Objectives
- To understand transporters and transporter regulation in traditional and nontraditional tissues and barriers
- To learn about transporters as novel drug targets
- To discuss recent advances in in vitro-in vivo extrapolation for predicting drug transporter-mediated clearance and drug-drug interactions (DDI)
- To inform about novel humanized transporter animal models
- To understand the Food and Drug Administration’s regulatory perspectives with regard to DDI guidances and in vitro transporter studies
Register today!
Thought Leadership and Sponsorship Opportunities
Contact AAPS to discuss thought leadership and sponsorship opportunities at workshops.
Erik Burns, Ed.D., M.B.A., M.A. | +1.703.248.4738
