Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Louise Leach, Program Manager, Medical Information
What do you do at ProPharma? How does your role support improving the health and safety of patients?
ProPharma has been a significant part of my life, I have been with the company for eleven years now. I work as a Program Manager in Medical Information, and I manage a team of Drug Safety Assistants across the EU.
Together with my experienced team we provide a range of Product Quality Services to our clients. One of the main areas of our role is to provide the day-to-day management of all Global Serialization aspects from intake to closure. Our work in this area, along with the other services we provide, plays a vital role in safeguarding patients from the risk of receiving any harmful products.
What is a current trend you're seeing in the industry and how does it impact our clients and patients?
Effective November 27th, 2023, there will be changes to the requirements of the Drug Supply Chain Security Act (DSCSA) in the USA. These changes will facilitate the electronic tracking of specific human prescription drugs, enabling their traceability from origin to the patient.
In 2017, the DSCSA introduced serialization- a requirement for manufacturers and repackagers to utilize serial numbers in preparation for package-level tracking. Each product gets equipped with a new 2D Barcode containing four pieces of information:
- Product Code / Global Trade Item Number / National Trade Item Number
- Serial Number
- Lot Number
- Expiration Date
Starting in 2023, package-level tracking will become mandatory. As a result, our clients will need to implement a secure and interoperable track and trace solution, enabling the establishment of a comprehensive electronic system for tracking products at the package level.
What's your number one goal / focus right now?
With the introduction of this new legislation, significant changes are expected for some of our clients. Therefore, my current primary goal is to provide them with support and assure them that our company possesses extensive expertise in this domain and is available to assist.
We can offer various services related to serialization, including:
- Downloading and consolidating the electronic alerts received via their chosen electronic system
- Processing all cases that have received a false/negative response as Product Quality Complaints (PQC)
- Requesting the authenticity verification of products (when necessary)
- Conducting any appropriate follow up if this is applicable
- Sending any required cases to their quality team for conducting Technical Assessments
What do you like best about working with clients?
Over my eleven years at ProPharma, I have had the privilege of working with diverse clients, each with unique requirements within the industry.
When working alongside our clients, you truly witness how the joint efforts can significantly impact and improve the lives of millions worldwide.
We recognize that building strong working relationships with our clients is crucial for their long-term business success.
Our clients trust and value our extensive knowledge of the pharmaceutical industry, which forms the foundation of our strong relationships based on trust and effective communication.
What is unique about our culture at ProPharma?
At ProPharma, we foster a culture that embraces diversity, encourages you to be yourself and strive for the very best.
As an equal Opportunity Employer, we strongly believe in fostering diversity, inclusion, equality, and a sense of belonging, creating a culture where everyone feels welcome.
The emphasis ProPharma places on equality, diversity, and inclusion empowers you to:
- Succeed
- Remain happy and motivated!
- Better serve a diverse range of our clients
- Improve ideas and problem-solving!
