April 23: Short Course*: Regulatory CMC Training - The Basics to Prepare for the CMC Workshop
April 24-26: Workshop

*Short Courses require separate registration.

Why come to DIA's CMC Workshop over any other CMC event?

1. This workshop has a laser focus on regulatory applications and translations to technical and quality processes – the strategy behind the science. How do regulations and guidelines inform the processes of this industry? This is the setting to find out.
2. One word: global. We will facilitate discussions with a highly global, regulatory focus, concentrating on regulations and guidelines from multiple ICH and non-ICH regions by regulatory authorities from those regions.
3. Multi-track. One track and one focus will not cut it for DIA. This is truly comprehensive content that will meticulously cover regulatory, technical, and GMP/Quality processes and how they work together.
4. No important topic unturned. We will address a broad array of innovative products: drugs (small molecule), complex products/generics, large molecules (biologics), biosimilars, and drug device combination products. This is unprecedented in any other offerings this year! No other meeting will have this scope and depth!

This program was developed by the CMC Working Group of the DIA Regulatory Affairs Community.

This program is co-sponsored with the American Association of Pharmaceutical Scientists.

New This Year

• Preconference Short Course to prepare entry and early intermediate level professionals for the workshop content
• 3 concurrent breakouts covering the topical themes of: GMP/Quality, Regulatory/Dossier, and Technical Aspects of CMC
• 22 sessions, including four plenary sessions in: Accelerated Programs, Innovative Technologies with a focus on Continuous Manufacturing, Life Cycle Management using ICHQ12, and the Global Regulators Update
• 18 breakouts – these are complete sessions addressing the three topical themes

Hot Topics

• Addressing regulation, development, and technical issues for large and small molecules
• Global perspectives: Regulatory and industry representation on requirements and issues from major global regions: US, EU, Japan, Asia-Pacific, Latin America, and Middle East (View DIA's complimentary webinars on CMC Regulatory Requirements in Sub Saharan Africa and Maghreb
• Case studies and interactive discussions to address the CMC challenges for today’s products