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.
In this webinar, we explore two scenarios that can open Medical Affairs up to censure. Scenario one explores participation of commercial team members in Medical Advisory Boards and scenario two looks at the implications of a commercial team member requesting a medical team member to participate in a thought leader meeting.
Real world data (RWD), when captured and analyzed, produces the Real-World Evidence (RWE) that underpins the economic case for innovative medicines. This Webinar aims to provide practical insight into the challenges surrounding RWD and RWE generation with interactive conversation on how individual companies are approaching these challenges.
Examine the current state & future of HEOR data in healthcare decision-making; discuss strategies to build strong relationships with payers, the medical community, and patient advocacy groups; determine the impact and value of evidence-based pricing and payment
This Webinar will discuss the process of investigator initiated research program followed across industry. The process is initiated externally by submission of IIR application via company website followed by internal company review and decision making process. This results in the execution of IIR study contract between the company and the Institution after which the study is initiated by the Investigator.
This Webinar discusses current trends and anticipated innovations, including the use of outcomes-based agreements; why traditional contracting may not be enough to address the needs of both payers and pharma manufacturers; and insights on the key payer engagement issues you should be considering today to optimize the market success of your products.
Recognize why networking and alignment is key to a successful Medical Affairs strategic plan; discuss the steps involved in strategic planning process and associated tools and templates; describe Global-Regional-Local alignment and implementation… where do you start? Select which functions you include when building your global Medical Affairs strategy.