November 07 - 08, 2018
TBD

Regulatory & Operations Day

7:45 am - 8:15 am Registration & Morning Jumpstart

8:15 am - 8:30 am Chairperson’s Welcome & Opening Remarks

8:30 am - 9:15 am Keynote: Teamwork for Track & Trace—From Data Systems to Packaging Lines

Tom Smith

Director - Global Standards
GS1

9:15 am - 10:00 am Spotlight Session: Regulatory Challenges & Opportunities in Pharma Smart Packaging & Labeling

Suraj Ramachandran, Director, Regulatory Affairs at Merck

Suraj Ramachandran

Director, Regulatory Affairs
Merck

10:00 am - 10:45 am Solutions Showcase: See the Latest Technologies Driving Innovation in Pack & Label

Lisa Kelsey, Head of Commercial Labeling at Genentech

Lisa Kelsey

Head of Commercial Labeling
Genentech

Krishna Kotha

Associate Director - Quality Assurance, External Manufacturing
Dr. Reddy's Laboratories

Haymanot Nadew

Manager of Regulatory labeling and Distribution
ProMetic

11:30 am - 12:30 pm Networking Luncheon—Mingle in Our Lunch Lounge

Pack

12:30 pm - 1:15 pm Regulatory Spotlight: Serialization NeXt—Implications for Packaging Operations & Aggregation

Pack

1:15 pm - 2:00 pm Overcoming the Lack of Qualified Line Operators
Ryan Stoeckel, Sr. Manager, Procurement and Strategic Sourcing at Ironwood Pharmaceuticals

Ryan Stoeckel

Sr. Manager, Procurement and Strategic Sourcing
Ironwood Pharmaceuticals

Label

12:30 pm - 1:15 pm Regulatory Spotlight: Serialization NeXt—Challenges for Labeling Operations & Aggregation
Ranjith Abraham, Senior Regulatory Affairs Labeling Specialist at Teva Pharmaceutical

Ranjith Abraham

Senior Regulatory Affairs Labeling Specialist
Teva Pharmaceutical

Label

1:15 pm - 2:00 pm Regulatory Spotlight: Beyond Serialization—Crucial Labeling Regulations
Harsh Patel, Senior Manager Regulatory Affairs at Glenmark Pharmaceuticals

Harsh Patel

Senior Manager Regulatory Affairs
Glenmark Pharmaceuticals

2:00 pm - 2:15 pm Afternoon Recharge—Continue Conversations Over Snacks & Refreshments in the Exhibit Lounge

2:15 pm - 3:00 pm Igniter Discussion Groups

Group A: The Regulations Keeping You Up at Night
 
Group B: How to Facilitate Interdepartmental Communication
 
Group C: Track & Trace & The Opioid Crisis

8:00 am - 8:30 am People’s Choice Awards & Community Goal-Setting

Workshop A

3:30 pm - 5:30 pm Workshop A: Smart Packaging Today, Tomorrow, & Beyond (Back By Popular Demand)

Workshop B

3:30 pm - 5:30 pm Workshop B: Digital Printing for Pharma Labels (New for 2018)
Ranjith Abraham, Senior Regulatory Affairs Labeling Specialist at Teva Pharmaceutical

Ranjith Abraham

Senior Regulatory Affairs Labeling Specialist
Teva Pharmaceutical