Monday, October 26, 2009
8:00 Registration and Morning Coffee
8:15 Barnett Welcome and Opening Remarks: Maximizing Training in the Current Regulatory Environment: Turning Risk into Opportunity
Naila Ganatra, General Manager, Barnett International
8:25 General Information and Introduction of Chairperson
Rachel Meyers, Associate Director, Barnett International
8:30 Chairperson’s Opening Remarks
8:45 Why Train? What the FDA Warning Letters Tell Us
Barbara van der Schalie, Clinical Training Manager, Clinical Monitoring Research Organization, SAIC-Frederick, Inc., National Cancer Institute at Frederick
While the Good Clinical Practices (GCPs) do not clearly mandate specific training requirements, a review of the FDA Warning Letters over the past several years indicate increased scrutiny of the qualifications of clinical research staff. This presentation will provide an overview of the clinical research-associated FDA Warning Letters and associated trends. While training is not the primary focus of FDA Warning Letters, the number of training-specific citations in FDA Warning Letters has increased significantly over the last 3 years. This is significant, since the GCPs do not specifically mandate training requirements, as the other GXPs do. The audience will learn not only the general trends in compliance indicated by the citations, but also a systematic approach to evaluate their training program for thoroughness and quality.
9:30 Training a Global CRA Workforce: Using Technology to Maximize Learning
Sheila Gwizdak, Director, Development Operations, Pfizer, Inc.
Training a global CRA workforce of both internal and outsource staff is a huge financial and logistical challenge for every pharmaceutical company. This presentation will describe how Pfizer approached their CRA training program in a multi-pronged approach that utilized technology in order to maximize use of resources. This approach has not only been successful in training the global CRA workforce but has increased the quality of monitoring. The audience will gain insight into delivering a training program for a global audience. They will learn how to use technology to maximize their resources. The audience will also be able to see that this program has had a direct impact on the quality of Pfizer’s clinical studies.
10:15 Coffee Break and Exhibit Viewing
10:30 Approaches to GCP Training: Best Practices and Lessons Learned from Industry Experts
Sharon L. Fernandes, Associate Director, Clinical Operations Training & Communications, Shire Pharmaceuticals
Good Clinical Practices are a critical success factor to ensuring regulatory compliance while conducting clinical trials in a global environment. Not only are pharmaceutical companies responsible for ensuring internal GCP training of their clinical colleagues, but they are accountable for the training of their external partners. This presentation will share best practices used at Shire to ensure that colleagues and partners have been trained via various learning methods, and how the learning can be accounted for during a regulatory inspection.
11:15 Roundtable Session #1: Effectively Training Global and Remote/Field-Based Teams: Best Practices from the Field
As we move from classroom-based training to training remote and global teams, new challenges come into play. In this interactive session, attendees will participate in discussions about what has worked, what has not, and how we can move away from making training initiatives a “box-checking” exercise.
12:15 Luncheon
1:30 Utilizing Competency Based Training for a Global Clinical and Global Manufacturing Operations Organization
Lisa Joseph, Associate Director, R&D Training, Biogen Idec
Lorie Aziz, Senior Manager, Technical Training, Biogen Idec
In late 2007, Biogen Idec embarked on a clinical quality improvement program, one aspect of which was the development of a more robust clinical training program. In parallel, the global manufacturing group also embarked on a similar program. Each functional area within Global Clinical Operations and Global Manufacturing designed “competencies” or topics that were relevant to their area based on job profiles, current requirements, and main roles and responsibilities of their function. The focus stayed on task or knowledge based competencies (“hard skills”). This presentation will give an overview of the plans and tools used from planning through initial implementation, as well as challenges and opportunities along the way. This presentation will give an overview of one company’s implementation of such a system for two diverse organizations, and perhaps encourage others down the same beneficial path.
2:10 Even GCP Training Can Be Interesting: Making Clinical Training More Interactive and Effective
Eileen Caramanica, Clinical Project Manager, Global Clinical Trial Management, Schering-Plough
Training doesn’t have to be boring! Add interactivity and enjoyment to your training with techniques that will increase your effectiveness as a trainer. By learning adult learning methodologies imbedded throughout this session, you can engage your audience and have them better retain your information. Several techniques (including a skit) will be demonstrated - don’t be surprised if you’re interactive in this session! Attendees will learn how to conduct more interactive clinical training, make clinical training more interesting and enjoyable, and most importantly, make clinical training more effective ensuring your audience retains more.
2:50 Partnering Effectively with Subject Matter Experts (SMEs) for Optimal Training Collaboration
Diana Yadgir, Manager, Functional Excellence, Clinical Research Exploratory Development (CRED) Operations, Genentech
As an advocate for the learner, a primary goal of the training professional is to help people realize their potential through learning events. However, research has shown that poorly designed or delivered training can actually leave the learner less informed. In addition, any learning that does not work is expensive. Most training development involves working with Subject Matter Experts (SMEs). With effective collaboration and appropriate coaching by training professionals, SMEs can learn to more efficiently provide their valuable expertise for training material content and also effectively assist with the facilitation of instructor-led training.
3:30 Refreshment Break and Exhibit Viewing
3:45 Re-Thinking the Goal of Informed Consent Training
Randi Misnik, BS, Senior Clinical Operations Manager, Teva Neurosciences
This discussion looks at the original rationale and intent of the Informed Consent Forms (ICFs) and how far that “we” in the research industry (i.e. Sponsors/Investigators) have strayed from the original intent in ensuring that potential study subjects truly make an informed decision to participate in a clinical trial. To be discussed as well is how we, who are working in the industry, can improve on the written documentation and the process being carried out at the site level, and ultimately, how this impacts informed consent training.
4:25 Roundtable Session #2 (choose one):
A) Defining Clinical Training Department Responsibilities: Creating Stakeholder Accountability
B) Employing Social Media in Training Initiatives: Twitter, Podcasts, Wikipedia, Social Networks, and YouTube
C) Strategies for Maximizing Training Resources in Small- to Mid-sized Companies
D) Regulatory Perspectives on Compliance Training: Current Climate Considerations
5:15 Close of Day One
For more information, please contact:
Naila Ganatra
General Manager
Barnett International
a division of Cambridge Healthtech Institute
Email: nganatra@barnettinternational.com
Phone: 215-413-2471
Rachel Meyers
Associate Director
Barnett International
Phone: (413) 527-3056
Email: rmeyers@barnettinternational.com
For exhibit and sponsorship information, please contact:
Arnie Wolfson
Manager, Business Development
Barnett International
a division of Cambridge Healthtech Institute
Email: awolfson@healthtech.com
Phone: 781-972-5431