Presenter: Satish Tadikonda, Ph.D., President, Virtify, Inc.
Over the past few years, Life Sciences companies have been under intense regulatory pressure globally to disclose a wide variety of clinical information through the registration of trial protocols or the posting of clinical trial results. As a result, these companies are looking to streamline their process to conform to current and upcoming clinical trials disclosure mandates.
All pharmaceutical, biotechnology and medical device companies are forced to consider how best to meet the mandates for clinical trials disclosure and the upcoming directives for disclosing adverse effects coming in the Fall of 2009. This webinar will present the important considerations in business process changes and technology available to predictably and consistently prepare quality submissions designed to meet those internationally disparate clinical trial disclosure requirements.
During this webinar, Dr. Tadikonda will address:
- How to streamline your current processes to more effectively comply with today's clinical trial disclosure mandates and future directives
- How to optimize your clinical trials disclosure solution as an integral part of an enterprise-wide structured content management strategy
- What impact new clinical trials disclosure solutions will have on existing processes, infrastructure investments and legacy systems
At the conclusion of the presentation you will understand:
- Specific requirements of the transparency mandates
- Upcoming XML standards for clinical trials disclosure
- Best practices for improving the compliance process(es)
- How to take complete control of the disclosure lifecycle
Your Speaker: Satish Tadikonda is President of Virtify, Inc, a global Life Sciences software company headquartered in Cambridge, MA. During his 20+ years of experience in the drug and medical device industries, he has worked on a number of long-term strategic initiatives and quick win solutions in the Life Sciences and Information technology sectors. With a deep understanding of drug discovery and development processes, Dr. Tadikonda has significant experience with global clinical and regulatory submission standards and has been actively involved in leading, or participating in, the development of electronic standards for the industry. Prior to Virtify, Dr.Tadikonda founded companies focused on electronic data capture and R&D systems integration and held senior management positions with leading companies in the pharmaceutical and medical device.