Overview

The fastest growing sector in the pharmaceutical industry is biologics. “Quality by Design (QbD)” and “The process is the product” have become long-time mottos for the regulators and companies developing new medicinal products also in this segment of the industry. Increased use of a wide variety of new technologies and expression systems makes GMP practices even more difficult to apply. Earlier stages of development and advancement of the product lifecycle through clinical stages to marketing can cause confusion about the regulatory status, since three branches of the Food and Drug Administration (FDA) are involved: the Center for Biologics Evaluation and Research (CBER); the Center for Drug Evaluation and Research (CDER); and the Office of Regulatory Affairs (ORA). In addition, compliance with international regulatory agencies is increasingly becoming a challenge.

The PDA Conference on the Development and Regulation of Clinical Trial Supplies is designed to share challenges and provide opportunities to organizations involved in manufacturing, packaging, release and distribution of new medical products.   Experience from proof of concept to marketing authorization will be demonstrated by industry leaders and supplemented by regulatory-approved case studies. Industry case studies will also outline benefits of the implementation of Quality Systems at the early stage of development and integration of quality practices into the pharmaceutical development. Additional highlights of the conference include an overview of the regulatory guidance for new medicinal product submission in the US and Europe, which will be presented by the FDA and EMEA speakers as well as international industry experts. One of the most significant aspects of the conference for attendees is the opportunity to meet and network with regulatory professionals and experienced personnel, ask questions and receive compelling answers from the regulators.

Who Should Attend

Departments
Regulatory Affairs | QA/QC | Process development | Analytical development | CMC | Operations | Pharmaceutical development | Product stability | Formulation development | Process and Validation

Level of Expertise
Executives | Senior Management | Deputy Qualified Personnel | Scientists/Technicians | Researchers | Bench personnel

Job Function
CMC leaders | Product managers | Pharmaceutical Development Scientists | Corporate and clinical professionals | QA/QC professionals | Engineering | Regulatory specialists | Project managers

Take Home Benefits

At the end of this conference, attendees will be able to:

• Describe product life cycle management
• Identify regulatory framework for new product submissions
• Define elements of Quality Systems required at each stage of development
• Compare strategies at early and late stages of development and their regulatory impact
• Identify main components of material release and distribution to the clinical sites
• Explain outsourcing production and clinical operations to contract organizations

Contact

For conference inquiries, please contact:

Paula Pagano
Senior Programs Manager
Phone: +1 (301) 656-5900 ext. 149
Email: pagano@pda.org

For more information about obtaining a U.S. visa, visit http://www.unitedstatesvisas.gov.