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Medical Affairs Collection - Report Bundle

  • October 2013
  • -
  • Firstword Pharma

Medical Affairs Collection - Report Bundle consists of all 5 reports from our Medical Affairs Report Series.

Reports Included

1. MSL-KOL Engagement: delivering value under new rules (May 2013)
2. Ensuring Optimal Medical Affairs Performance: Delivering Measurable Value (May 2013)
3. The Path to Product Inclusion in Clinical Guidelines: Strategies for Success (February 2013)
4. Pharma and the mHealth Revolution - engaging with mobile-enabled physicians and HCPs (February 2013)
5. Publication Practices for Compliance and Credibility (December 2012)

MSL-KOL Engagement: delivering value under new rules (May 2013)

The role of MSLs is changing. Once a position that straddled the area between scientific insight and sales, global demands for transparency and disclosure in MSL-KOL relationships have caused a seismic shift.

For the pharmaceutical industry, the fallout is clear: companies are now examining how MSLs are engaging with KOLs and creating distance between their unbiased, informational role and explicit, promotional behaviours. Even where there is no clear, official guidance overseeing MSL-KOL relations, many companies are implementing their own rigorous measures for handling training, standard operating procedures and monitoring.

Like its best-selling predecessor, MSL-KOL Engagement: delivering value under new rules tackles the evolving MSL-KOL relationship head on. Cast against tougher regulations being implemented worldwide such as Sunshine Act in the US, the report not only addresses the heightened need for measurable, demonstrable MSL compliance, but how companies can better grasp the legislative landscape and develop on-going strategies to support long term MSL-KOL interactions. In an era of increased scrutiny, penalties and skepticism, MSL-KOL Engagement: delivering value under new rules is an invaluable and timely roadmap for any company.

This report provides:
Access to the most current and up-to-date strategies developed by companies ensuring MSL-KOL relationships remain without censure
Insight into the very latest US and European regulations and legislation governing MSL-KOL interactions
Discussion of proactivity versus reactivity, off-label information, standard operating procedures, training/tracking, and how to incentivise MSLs
Measures that demonstrate MSL value without crossing the line into promotion
Insight into how MSL-KOL relationships can be maintained over the long term

Ensuring Optimal Medical Affairs Performance: Delivering Measurable Value (May 2013)

In this era of transparency, Medical Affairs is rapidly becoming the new voice of Pharma.

Positioned at the interface between Commercial and R&D, and as the hub of communications with key stakeholders, Medical Affairs is in a prime position to lead Pharma’s transition from merely selling drugs, to playing an integral role in the entire healthcare ecosystem.

The perceived importance of this function is reflected in the growth of its budget and responsibilities. However, the value that Medical Affairs brings to an organisation is notoriously hard to measure. Yet effective measurement can lead to greater efficiency and expertise in bringing stakeholder insights into the company.

Ensuring Optimal Medical Affairs Performance: delivering measurable value is an invaluable resource for anyone interested in the evolution, measurement, and management of Medical Affairs – including Medical Affairs directors; Brand, MSL, and IIT managers; and Global Communications executives.

This up-to-the minute report draws on the expert opinions and experiences of Medical Affairs leaders at top Pharma companies including Astellas, Bayer, Boehringer Ingelheim, and Ferring.

The Path to Product Inclusion in Clinical Guidelines: Strategies for Success (February 2013)

Clinical guidelines are taking hold in the practice of medicine. Though not always voluntarily followed in real-world patient care, they increasingly form the basis of formulary and reimbursement decisions, as well as the continuing medical education (CME) materials used by physicians.

In this guidelines-centric culture, it is more imperative than ever for drugs to be on the guidelines, and also harder than ever to influence the data that determines them.

Best practices around clinical guideline development call for independent analysis of raw data – untainted by financial gain or academic prestige.

In this tightly controlled and highly sensitive environment, what can Pharma do to maximise the credibility and visibility of its products?

Pharma and the mHealth Revolution - engaging with mobile-enabled physicians and HCPs (February 2013)

The media’s dubbed them ‘a doctor in your pocket’ and ‘health care helpers’. Yet despite the explosion of mobile apps in other industries, pharma has generally been slow to exploit the possibilities they represent. What are the hurdles facing the industry and who are the leaders overcoming them? How can companies develop a mHealth approach that both addresses end-user needs and key messaging? What does pharma need to know about regulatory and legal hurdles?

Concisely written and expertly researched, this FirstWord Dossier report succinctly addresses the issues surrounding the emerging mHealth industry—and finds the answers.

Publication Practices for Compliance and Credibility (December 2012)

Don’t miss this up-to-the-minute report on publication practices.

Pharma’s efforts to disseminate the results of its clinical research have never been under such intense scrutiny. Such high levels of suspicion make publication compliance and credibility two top priorities for pharma companies. GlaxoSmithKline’s recent well-received decision to open up its raw clinical trial data to independent researchers will only accelerate the rush towards transparency. The question for publication managers and planners is not whether to follow GSK’s example, but how. What is their response to an increasingly transparent environment? What must go into a publications strategy in order to comply with gold standards, meet stakeholder needs, and ultimately, gain credible exposure?

This timely new report will help anyone in the publications field discover ways to tackle new challenges and maximise new opportunities as open access transforms publishing.

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