Regulatory Harmonization Meets CMC Realities

For developers and manufacturers of biopharmaceuticals with international commercialization intentions, the concepts of regulatory harmonization and convergence sound like sunshine and roses. For CMC teams challenged to keep stride with shapeshifting and jurisdiction-specific changes, maybe not so much.

Now available On-Demand, Bioprocess Online Live tackles the hard questions around navigating international regulatory requirements, the work being done to streamline efforts, and how CMC leaders can best manage the ever-changing regulatory landscape.

Panelists include:

• Steve Chamow, Ph.D., Sr. VP of CMC at Alira Health
• Stefanie Pluschkell, Ph.D., Founder & CEO at InScope Coaching & Consulting LLC
• Matt Pillar, Chief Editor at Bioprocess Online