Navigating the North American pharmaceutical regulatory landscape – CPHI North America 2023 preview

As we prepare for CPHI North America from April 25–27 in Philadelphia, USA, CPHI Online caught up with some of the track sponsors to discuss how the show connects vital players within the North American pharmaceutical landscape. 

1. What does it mean for PLG to be attending CPHI North America this year? 

Events such as CPHI North America are critical for PLG not only to introduce our expertise across the product development cycle, but also to work closely with the innovators and disruptors within the industry bringing novel therapies to life. Being able to meet at an event like CPHI to discuss industry challenges and establish partnerships are what drive healthcare forward, and it’s important for us to understand how we adapt our own business model and expertise to continually meet these evolving challenges.  

2. Are there any regulatory compliance updates this year to consider at this year’s CPHI North America? 

The regulatory process is getting faster than ever. Improvements in data analytics and innovative tools like AI have had an astronomical impact on data management, prompting organisations to have constant hands-on management of their regulatory requirements. With the constant evolution in regulatory compliance, it’s important to not only stay informed of changes to specific regulations, but organizations also need to truly evaluate if their timeline is keeping up with a constantly streamlined regulatory process. 

3. Of what value are events such as CPHI North America to those involved in regulatory compliance and affairs? 

Events such as CPHI North America are important for individuals in the industry to gain perspective on what drives regulatory compliance and affairs. No two products, trials, or even processes are exactly the same, and with such a vast global pipeline of therapies, the regulatory process continues to adapt and incorporate diverse drug candidates. CPHI North America gives industry professionals an intimate view of how the regulatory process serves as a living, central framework to advance the drug development process, and foster communication and ideas across industry professionals that lay the groundwork for future improvements. 

4. What are some specific challenges for the North American pharmaceutical supply chain and regulatory landscape? 

There is certainly no shortage of challenges when considering a global supply chain. Health authorities, policies, and regulations at the local level add a further layer of complexity to an already intricate process. As the post-pandemic world of ever-increasing supply chain costs continue to factor into the drug approval process, it’s important for organisations to rely upon trusted experts to help navigate local health regulations to minimise delays and costs while maintaining compliance. 

5. What are you most looking forward to at CPHI North America? 

I’m extremely grateful for the opportunity to talk with some of the most important people shaping healthcare today. It’s incredibly motivating to see the passion and drive from industry professionals bringing new medicines to life. CPHI North America presents an opportunity to hear about new ideas, products, and obstacles our clients face, and allow organisations like PLG to innovate alongside our clients to offer new solutions.