To achieve adaptable and scalable trial execution, a mindset change and more flexible approach to data management is necessary. Join this webinar to hear industry experts discuss three key lessons learned when applying Agile Development Methodology principles into your work in data management.
Join Dr. David Gosalvez to see how R&D productivity can be improved in three critical areas: Lead Discovery, Screening and data capture. Register Now!
Serialization is a great achievement for our industry. However, most executives now realize that it is only part of the solution and serialization alone cannot solve the escalating problems of counterfeiting and diversion within the Pharmaceutical industry.
In this webinar we will discuss going beyond serialization and understanding why it’s not enough and the need to stay innovative and add value and protection to your current solutions. Register now.
Join as Diane Hayes, PHD, InCrowd President and Co-founder, reviews the results from the 2019 physician predictions survey and considers the year ahead. Register Now
This webinar will explore both Right-to-Try legislation and existing Expanded Access Programs, including:
- Understanding sponsor responsibilities under these programs and when products may be eligible for these program
- Evaluating options such as treatment protocols, treatment INDs, and emergency use
- Discussing development risks associated with participation in these programs
This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2), the pathway of choice. When executed properly, this regulatory pathway enables a lower cost, lower risk, and faster path to approval and market. Register Now!
Navigating patient-reported outcomes (PROs) such as unobservable symptoms, treatment satisfaction, quality of life, and treatment adherence is a critical component of a patient centric healthcare system. Join our experts in the first of a three-part webinar series on PROs, as they provide insight on the foundational elements of PROs and recent regulatory trends. Register now!
This webinar will present a quantitative systems pharmacology case study which assesses a Lipid Nanoparticle to treat Crigler-Najjar Syndrome Type 1. Learn how the model was used to support translation from preclinical to clinical trials as well as first-in-human dosing.
Hear new results from one of the industry's largest, global clinical operations surveys, the Veeva 2018 Unified Clinical Operations Survey. The Veeva 2018 Unified Clinical Operations Survey examines the industry’s progress toward a unified clinical operating environment. Register Now
Join Joe Lipari, Director - Global Traceability from Systech, as we map out a proven route to serialization success along with Steve Kane, Head of Product Integrity Program Global IT for Shire and Ann Schaefer, Director - Supply Chain Management at Acorda Therapeutics. The panel will discuss complexity of the regulations, hurdles they overcame, and solutions that carried them over the finish line. Register Now.
Researchers are encumbered with a plethora of disparate data and analytic tools. These assets pose several challenges which need to be overcome to ensure they satisfy their intended purpose.
Watch this webinar to learn how real-time, self-service access to longitudinal patient data is changing the way researchers evaluate treatment effectiveness, safety, protocol design, and more. Register now.
In this webinar you will hear from industry experts on:
- How to manage stability challenges for accelerated approval programs
- Fit-for-purpose manufacturing strategies
- Overcoming scale-up challenges
- Developing a comprehensive solution for unexpected challenges
- Avoiding typical pitfalls in accelerated programs