Competency Directory – Medical Affairs Professional Society

Clinical Statistics for Non-Statisticians (Part 2 of 2)

March 27, 2019

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).

A Global Perspective on Conducting Early Access Programs

March 27, 2019

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.

Patient Engagement in Drug Development: An Opportunity for Medical Affairs

February 6, 2019

Understand the numerous ways in which partnership with patients can impact the development and commercialization of medicines; the current “patient centric” landscape in pharmaceutical drug development; recent findings related to the value of patient-centric trial design, and innovative approaches to engaging with patients across the study continuum.

Field Based Medical LCM in the Device and Pharma World

November 28, 2018

MSLs are becoming more important and playing key roles across the lifecycle in partnership with many others who play important roles. We will describe the landscape, drivers, and opportunities for engaging with customers across the lifecycle and how we socialize learnings across the organization.

Dust Off Your Scientific Communication Platforms: Updating, Implementing, and Operationalizing Them for Success

October 30, 2018

Ensure understanding of the basic components and processes involved in the development of a scientific communication platform (SCP); how to develop and/or update an SCP so that the scientific and value narratives are integrated; learn how to train and implement an SCP across functional teams; glean insights into tailoring a global SCP to a regional SCP

Clinical Statistics for Non-Statisticians (Part 1 of 2)

October 24, 2018

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

Value Assessment for Health Technologies – A Primer on Cost-Effectiveness Analysis and Health Technology Assessment

October 10, 2018

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.

Medical Affairs Excellence and Ethics & Compliance in the Evolving Healthcare Landscape – Collaborating and Leading by Example

August 30, 2018

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.

Compliance Considerations in Medical/Commercial Collaborations

August 30, 2018

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.

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