Core Curriculum

Tutorial name:
Core Curriculum

Day & Time:
March 18, 7:59AM - 4:45PM

Registration Fees
- Standard Rate	$295.00

Instructor(s):
Jim R. Wilkinson, PhD
Executive Director, Medical Communications
Amgen Inc., United States

Danielle Iobbi Ziernicki, PharmD
Director, Global Regulatory Policy and Intelligence
Janssen Reserach & Development, LLC, United States

Jackie Morton,
Research Information Specialist
Amgen, United States

Michael Cuozzo, PharmD
Director, Crisis Management - Global Consumer Care
Johnson&Johnson Consumer Companies, Inc., United States

Jihwon Im, PharmD
Principal Scientist
Genentech, A Member of the Roche Group, United States

Rebecca Falcone, PharmD
Senior Manager, US Medical Information Services
Sanofi U.S., United States

Kurt T. Kreiter, PhD
Director, Medical Information
Biogen Idec Global Medical Affairs, United States

Jennifer Totten, PharmD
Scientific Communications Specialist
Forest Research Institute, United States

Description:

This activity is specifically designed to meet the needs of individuals new to biopharmaceutical industry-based medical communications. Attendees will learn and discuss skill sets that provide value to both internal and external customers. Those who have been in their functional role for less than 1 year would gain the most from attending.

8:00-9:45AM CORE CURRICULUM – SESSION 1

8:00 – 8:30AM      Welcome and Introductions     
Jim Wilkinson, PhD
Following opening remarks, the Core Curriculum faculty will introduce themselves to the attendees and provide descriptions of their career paths leading to their current roles in Medical Communications. The faculty will then describe their current responsibilities, allowing the audience to begin to see similarities and differences in the practice of Medical Communications across the industry. A short networking and business card exchange will close out the opening talk.

8:30 – 8:45AM      Current Practices in Medical Communications
Jim Wilkinson, PhD
This short session will highlight the core and growing roles and responsibilities that Medical Communications professionals have taken to support health care professionals, patients and ultimately the commercial success of the business. Landscape changes within our industry, and how this may affect our job responsibilities, will also be briefly summarized.

8:45 – 9:45AM      Regulatory Environment and Medical Communications Practices
Danielle Ziernicki, PharmD
This session introduces the current regulatory environment that influences the activities of a US-based Medical Communications professional. An overview of the pharmaceutical industry and DDMAC regulations will be reviewed, along with the rationale for many of the activities common in Medical Communications departments which will include a case study presentation.

9:45 – 10:00AM          Break

10:00-12:00PM CORE CURRICULUM – SESSION 2

10:00 – 11:00AM  Helpful Tricks of the Trade 1: Advanced Literature Searching and Evaluation
Jackie Morton
Literature searching is a vital skill for all Medical Communications professionals. This session will review key medical literature database search strategies and each attendee will walk away with knowledge that can be applied immediately in their daily work. An interactive case presentation will be discussed by the faculty and attendees.

11:00AM – 12:00PM  Helpful Tricks of the Trade 2: Regulatory Resources in the Public Domain
Danielle Ziernicki, PharmD
There are multiple regulatory resources available for Medical Communications professionals, many of them for free. This session will review resources available in the public domain and how they can help you successfully deliver results. An interactive case presentation will be discussed by the faculty and attendees. 

12:00 – 1:00PM    Lunch

1:00 - 4:45PM CORE CURRICULUM – SESSION 3 AND 4
These two sessions will delve deeper into the challenging aspects of six different areas of our industry practices. This includes activities such as identifying the critical steps that a medical communications professional should take when receiving an inquiry, evaluating the sources of information/data available when preparing a response, the importance of fair balance and documenting responses. Topics will also include formulary dossier communications, promotional review, global activities, interactions with medical science liaisons (MSLs) and activities at scientific congresses. Role playing and mock examples will be used to re-enforce principles that emphasize the importance of our role to the industry and to the customers we serve. Attendees will be presented with real-life scenarios that represent challenges that are common to our roles and will be asked to discuss and share their responses to the situations.

1:00 – 2:45PM      Session 3

1. Best Practices for Handling Medical Inquiries
   Mike Cuozzo, PharmD
2. Promotional Review Committee Overview
   Jihwon Im, PharmD
3. Strategic Role of Medical Communications at Medical Congresses
   Rebecca Falcone, PharmD

2:45 – 3:00PM      Break

3:00– 4:45PM      Session 4

1. Global Considerations for Medical Communications
   Kurt T. Kreiter, PhD
2. AMCP Dossiers and the Managed Care Perspective
   Jennifer Totten, PharmD
3. Effective Interactions with the Field-Based MSLs
   Jim Wilkinson, PhD
   

Event	Credit Type	Max Credits	CEU
Core Curriculum	RN ACPE IACET	7.25 7.25 7.25	0.000 0.725 0.700

Learning Objective(s):

At the conclusion of this session, participants should be able to:

1. Identify activities that Medical Communication professionals participate in that provide global value to both internal and external customers, as part of working in interdisciplinary teams.
2. Describe how the regulatory environment influences Medical Communications practices.
3. Identify regulatory resources available and how to apply them to your day-to-day work.
4. Identify critical steps that a Medical Communications professional should take when receiving an unsolicited inquiry, including evaluating the available data and sources of information.
5. Determine the important elements of planning for a scientific presence at a medical congress, including the provision of medical information and the optimal use of technology at this type of venue.
6. Recognize the importance of the payer environment by evaluating AMCP/EBM dossier requirements.
7. Describe the distinct scientific value that Medical Communications provides on promotional review committees and how to balance the provision of marketing support while avoiding common pitfalls in that role.