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Challenging Triangle in Pharma: New Technologies, Limited Regulator Resources, & Timely Delivery to Patients

Søren Thuesen Pedersen
Challenging Triangle in Pharma

The past few years have placed regulatory issues at the heart of our activities. Some of these issues include:

  • EU/US Mutual Recognition agreement
  • PIC/S Mutual Reliance
  • Draft Guidances on Continuous Manufacturing but also on ATMPs

These are all issues that have the potential to fundamentally change “the way we work” in within the pharmaceutical manufacturing industry.

On a more personal note, if I were to dedicate my professional life to one single cause it would be Regulatory Harmonization and Convergence.

This is for one simple reason: it does not add value to the patient to have redundant processes in product regulatory approval and life cycle management. Furthermore, it allows us to focus on areas that need not require additional scrutiny. This conference will offer some of the latest insights into Pharmacopoeias and the EU/US Mutual Reliance Program on GMP Inspections.

The 2019 ISPE Global Pharmaceutical Regulatory Summit is right around the corner and I think it’s fair to say this conference will offer many takeaways that will address the challenges mentioned above making it a ‘Must Attend Event’ if you work within pharmaceutical manufacturing industry and regulatory affairs.

There is a challenging triangle in the areas of new technologies, limited regulator resources, and timely delivery of new technologies to patients.

Development & Implementation of New Technologies

The pharmaceutical industry is striving to develop new technology to improve product quality by adopting novel manufacturing technology or new product design. In recent years, there have been successful cases of new technologies (e.g. continuous manufacturing, 3D-printing, novel control strategy based on predictive modeling, etc.) approved by global regulatory agencies. However, the pharmaceutical industry may still face technical and regulatory challenges regarding the development and implementation of a novel technology. The potential concerns may present due to the unfamiliarity of the novel technology for both industry and regulatory agency. This conference will give knowledge about cutting-edge technology developments and about experiences in interacting with regulatory agencies during the development and regulatory submission and approval process.

Issues of Limited Resources

Health authorities face resource challenges to review the volume of drug applications and to train reviewers for complex and novel technologies. Pharmaceutical companies face challenges of different and changing global regulatory requirements for their products to be accessible to patients. Recently, work-share programs have emerged such as ACSS (Australia, Canada, Singapore, Switzerland) to help regulatory authorities share resources with each other and help reduce the regulatory burden to the industry by harmonizing their regulatory requirements. The goal is to have a better understanding of how these work-share programs operate and how more companies can participate. Another important area of interest is to understand how the work-share program impacts the lifecycle management of the product and if the program can potentially expand to other countries.

Global Access to New Drugs

In the past decade, emerging technologies have made tremendous advances in drug discovery. It is important that access to these new medicines is available to patients globally. However, there are global challenges preventing medicines to be delivered to patients in a timely fashion. The development of patient centric or clinically relevant specifications builds on existing industry guidance and utilizes the science and knowledge generated through the development and lifecycle of a pharmaceutical product. By taking this understanding and applying it to establish specifications that focus on the patient, rather than simply the batch data available at time of marketing application, significant benefits can be gained for both patient and industry.

In addition to sessions addressing these global pharmaceutical issues, the 2019 ISPE Global Pharmaceutical Regulatory Summit will offer in-depth and interactive presentations from various ISPE initiatives teams. Be that from the APQ – Advanced Pharmaceutical Quality team on the latest insights into Quality Metrics; or from our Pharma 4.0™ team on such topics as how to utilize the abundance of data available to modern pharmaceutical manufacturing in new and better ways.

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