15 July 2009
12:00-1:30 pm ET
As the cost of development continues to rise, it is becoming increasingly important for companies to bring products to market as quickly and efficiently as possible. Outsourcing various aspects of the development process is an effective strategy for most companies that have limited financing and staffing resources, lack expertise in specific aspects of the product development process or do not have facilities needed to perform developmental studies.
Although most regulatory professionals are not responsible for selecting or managing their company’s contractors, the information and data derived from outsourced services will ultimately be used in regulatory submissions. Therefore, as a regulatory professional, it is in your best interest to provide input into the vendor selection process.
This important Webcast will focus on outsourcing as it relates to nonclinical pharmacology and toxicology good laboratory practice (GLP) studies, clinical studies and regulatory submissions. It will provide basic information on what to look for in selecting preclinical and/or clinical contract research organizations (CROs) and why clear and frequent communications are essential to a successful business relationship. The importance of quality agreements and other documents that describe the roles and responsibilities of both the company and the CRO will be discussed, as will the importance of specifically defining the expected final deliverable.
A firm understanding of these fundamental yet crucial aspects of the selection and management contractors will allow you to provide well-informed, valuable feedback to your organization as it considers outsourcing.
Professional Levels: II, III
Learning Objectives:
Upon completion of this Webcast, participants should be able to:
- List criteria to be considered when selecting preclinical and/or clinical contract research organizations (CROs)
- Communicate effectively with contractors
- Describe the characteristics of well constructed quality agreements and the important role they play in relationship management
- Utilize tactics that will allow you to provide input into your organization’s vendor selection and management processes
Who Should Attend:
Directors, managers, specialists and associates who actively participate in product development and approval processes.
Speaker(s):
David Pepperl, PhD, senior consultant, Biologics Consulting Group Inc.
Pepperl is a pharmacologist and toxicologist, with preclinical product development experience with both small molecules and biologic products.
Michael A. Trapani, MS, MBA, senior consultant, Biologics Consulting Group Inc.
Trapani has held senior level regulatory and quality affairs positions with biopharmaceutical, medical products companies and contract research organizations. He is an active member of RAPS and most recently was a member of the Board of Editors of Regulatory Focus magazine.
Cost: Members: $295 USD; Nonmembers: $395 USD
Cost is per site - unlimited participants
Online registration will close at 12:00 pm ET two days prior (48 hours) to the Webcast. Individuals wishing to register after this time may register only by phone.
Written cancellations received by 11:59 pm EST (5) business days prior to the Webcast will be refunded the registration fee minus a $100 administrative fee.
All you need to participate in a Webcast is Internet access and a computer with speakers and a sound card. Please note: a telephone connection will no longer be used to broadcast the presentation audio. Expert presenters virtually deliver the presentation via the Internet, while participants simultaneously view the PowerPoint slides on their own computers. A live Q&A portion following the presentation enables interaction between participants and presenters.
Questions? Call the RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.
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