Navigating Through the Global Regulatory Framework

9:00 am Chair’s Opening Remarks

9:15 am Integration Regulatory Teams in Industry CM Process Development

Synopsis

• How regulatory and Process development teams can work together to expedite speed to market
• Collaboration between internal regulatory teams and external regulatory bodies
• Enforcing benefit/risk regulatory assessment

9:45 am Panel Discussion: Where’s the Real Barrier to CM Implementation; Regulatory, Strategic or Economic?

Synopsis

• Contrasting the relative regulatory expectation for small molecule vs biologics
• What pitfalls in regulatory submissions do regulators see most often?
• Where does continuous have the most impact, small molecule, biologics? Innovators or generics?

10:30 am

Speed Networking – Get Matched With Your Fellow CCP Community Members

12:40 pm

Networking Lunch

Synopsis

• Visit our exhibition space for downloadable bonus content
• Connect with 1-2-1 video chats

3:00 pm

Afternoon Break

Designing A Winning Business Case for Continuous

3:30 pm Session Reserved for Emerson

4:00 pm A Holistic Approach to the Industry 4.0 Investment Agenda: Breaking Down the Fences Between R&D & Manufacturing

Synopsis

• Industry 4.0 should be understood as an investment agenda
• The usual fences between R&D and manufacturing can jeopardize the implementation of Industry 4.0 assets
• Success requires that business development treats R&D and manufacturing as a continuum

5:00 pm

Chairs Closing Remarks

5:15 pm Celebrating Half a Decade of CCP: Evening Reception Including Panel Discussion on Diversity in Pharma Manufacturing