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Regional Markets

Don’t forget to bring your headphones!

This year, our theaters on the show floor will be ‘silent theaters’, bring your own headphones to listen to speaker audio through your mobile device.

Raymond Ng
Accestra Consulting Company
Senior Regulatory Affairs Manager
Purna Thakker
ADPT Solution
Founder & CEO
Moshmi Sanagavarapu
Director of Analytics
Ram Balani
Dean Calhoun
Affygility Solutions
President and CEO
Mundhir Al-Hakim
Exhibition Director, CPHI Middle East
Juan De Villafranca


Location: Conference Theater 2 | Date: May 7th 2024

11:30-11:55 (EST)
Boosting DSCSA Regulatory Preparedness for FDA’s Drug Supply Chain Security Act Compliance with Copilot Integrated Generative AI/ML
  • Why DSCSA  was created by US Congress, some history of past undertakings
  • Who’s who and what’s what with DSCSA trading partner roles for drug manufacturers, repackagers, wholesale distributors, 3rd party logistics & service providers, dispensers 
  • Challenges for regulatory compliance with DSCSA from various FDA  DSCSA pilot project participants  including key findings from FDA’s Final report assessment on participant pilot reports submitted to FDA
  • Why many remain unprepared-search gauntlet with US FDA.Gov website abysmal metadata searching specific to DSCSA vs Google browser search inherent  web noise or clutter when seeking DSCSA relevant context specific information
  • Illustrate  new AI/ML  Microsoft Copilot & chatbot platform/ technology with underlying  AI/ML generative technology via ChatpGPT-4 LLM  under the hood
  • Extending Copilot with your custom enterprise external data and leveraging cloud-based Microsoft Sharepoint Online Full-Text search on actual US FDA collections hosted within Sharepoint Online to fact check generative response accuracy by You-the-Human
12:00-12:25 (EST)
Difficulties Meeting US FDA Regulatory Requirements
12:30-12:55 (EST)
Bridging the Healthcare Access Gap with AI

US healthcare industry has undergone tremendous digital transformation in recent years, but critical care access to lower income ethnicities is still in its nascency. This population have historically showcased substantial hesitation to seek any timely medical assistance. While lack of sufficient financial resources plays a critical role, the existing cultural and knowledge barriers also contribute significantly to widening the healthcare access gap.

Recent technological advancements have opened avenues that can identify both patients and their caregivers, who play a critical role in patients’ diagnosis, building healthcare knowledge and instilling confidence in required therapeutic procedures. A digitized go-to-market strategy featuring connected media coupled with smart wearable devices and location encoding can be collectively leveraged to reach this key audience group. The AI/ML algorithms can be thoroughly trained to identify useful targeting signals from user's digital presence.

These user interactions can be further assimilated to identify contextually relevant interest topics and decipher potential audience on digital avenues to serve that brand message. In conclusion, grasping the true health access journey of any lower income ethnic group is important to design beneficial touchpoints that can alleviate patients’ concerns and allow them to break their own access barriers and opt for appropriate healthcare.

13:30-13:55 (EST)
The CPHI Middle East Vision
14:00-14:25 (EST)
Unlocking Opportunities: Exploring the Middle East Pharma Market

Discover the burgeoning pharmaceutical landscape in the heart of the Middle East, where Saudi Arabia stands as a beacon of opportunity. Explore new frontiers and understand the potential for innovation and growth in this dynamic market.

14:30-14:55 (EST)
New Business Opportunities Between USA and Mexico - Supply Chain Resiliency

One of the problems that today US suffers is the persistent shortages in pharmaceuticals. The concentration of key products in countries as China and India is a risk for the United States and a necessity to diversify and include new partners. Special efforts are needed to have supply chain resiliency. Mexico’s pharmaceutical industry is one of the most developed in the region with not only specialized and skilled workforce but also high standards and the capacity to produce effective medicines that can help reduce those shortages. United States and Mexico can take advantage of nearshoring to improve pharmaceutical exports to the US that will benefit both countries, by making them complementary in the supply chain in this critical sector.

15:00-15:25 (EST)
China Drug Master File (DMF) Comparing with U.S. and EU

This session provides an overview of the Drug Master File (DMF) regulatory framework and registration pathways covering Active Pharmaceutical ingredients (APIs), Excipients and Packaging Materials. The aim is to provide an overview of the local requirements and advise on the best and quickest route to the Chinese market. Thanks to the global harmonization efforts, the Chinese DMF regulatory system is becoming more similar with US DMF, EU ASMF and CEP requirements.

However, local requirements and gaps in the regulations still exists, this session shares the registration procedures, timeline and costs of China DMF and further provides a comparison of China DMF with U.S. and EU from various perspectives. Finally, this session shares the most common pitfalls in terms of technical requirements and provide hands-on tips to help minimize risks and issues with China regulatory authorities, and smooth DMF registration process in China.

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