Make Communications, Not War: Best Practices for Medical, Legal and Regulatory Review
This MAPS webinar details potential hurdles of the MLR review process, function alignment, and our changing MLR environment and possible solutions.
This MAPS webinar details potential hurdles of the MLR review process, function alignment, and our changing MLR environment and possible solutions.
What is company and medical affairs led education and how it is perceived by audience? What are the different perspectives existing among regulators, Pharma and agencies? What is the potential for disease state medical education by medical affairs?
OBJECTIVES: Identify the major trends and drivers towards digital transformation and drive Medical Affairs towards a digital future.
In this session, you will hear “insider tips” from three senior-level Medical Affairs leaders from leading multinational biopharma companies.
This MAPS podcast introduces listeners to social listening to gather insights and discusses implementation, value and technologies.
Part 2 of this series will discuss statistical analysis in clinical trials including null/alternative hypotheses; statistical assumptions (type I error, significance level, type II error, statistical power); hypothesis testing; Statistics used in RCTs, including type of outcome measures, analysis of time-to-event variables (plotting and interpretation of Kaplan-Meier curves).
Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.
Part 1 of this series will: define terminologies in statistics; explain different types of data (quantitative vs. qualitative); describe different ways in presenting summary data (such as proportions, means, medians, range and standard deviation); explain 95% confidence intervals; discuss bivariate analyses and appropriate statistical testing for quantitative and qualitative variables
Health technology and value assessment can be conducted using a variety of methods. Dr. Malone will provide an overview of those methods and an introduction on how to interpret the results from cost-effectiveness studies. This webinar will also discuss issues with defining value for health technologies, especially pharmaceuticals.
This Webinar explores: the role of Medical Affairs in guiding ethical decisions internally and externally; the impact of Medical Affairs beyond its remit; the importance of sharing best practices for the role of Medical Affairs in strategic brand planning, and the ethics and compliance considerations for Medical Affairs plans.
