Clinical Trials: Why is India Irresistible?

In recent years, India has proven itself as a solid-performing region for conducting clinical trials. As it has evolved and emerged, it has caught the attention of global pharmaceutical and biotech companies. The reason for the growth in this region is simple: India, with a population of over 1.15 billion people, has one of the largest patient populations in the world. In addition to its large patient population, India has nearly 700,000 specialty hospital beds, 290-plus medical colleges, and skilled English-speaking medical professionals.

In this session we examine the factors that have made India one of the hottest places in the world to conduct clinical trials. Attendees come away with proven strategies to overcome challenges and maximize the “India advantage.”

Clinical Trials: Why is India Irresistible? is being presented by Dr. Pramod Kabra, Director of Clinical Operations, with PRA International and airs on Thursday, January 28, 2010. For more details or to register, please visit our site at www.fxconferences.com

Leading Virtual Teams in the Pharma & Biotech World

The majority of work that gets done in the pharma and biotech industry is done with teams. But what has changed in the last decade is that most of these teams are now “virtual,” with many team members geographically dispersed. Not only are these team members remotely located, but they often work in both different time zones and country cultures.

In this audio conference, our speaker, who has travelled the globe working with virtual teams, offers insights and tips for building relationships and trust, maximizing collaboration, and achieving world-class results without the benefit of face-to-face teamwork.

Leading Virtual Teams in the Pharma & Biotech World is being presented by Lynda McDermott, President, of EquiPro International and airs on Tuesday, January 26, 2010. For more details or to register, please visit our site at www.fxconferences.com

Points to Consider when Presenting Documents for an FDA Inspection

It used to be that all controlled documents were stored as hard copy in a document center where they would be signed out for presentation to inspectors. These days, records are stored in a variety of computerized systems. They are typically printed out in the last minute and with minimum review. When these records are then made available to inspectors, they are often incomplete and inaccurate.

In this audio conference, our speaker provides an understanding of offical records, explores different strategies, and explains how to prepare your records for an FDA inspection in a more complete and accurate manner.

Points to Consider when Presenting Documents for an FDA Inspection is being presented by Ronald Eisenwinter, Quality & Regulatory Consultant and airs on Tuesday, February 16, 2010. For more details or to register, please visit our site at www.fxconferences.com

Are You Ready for MDD Amendment Directive 2007/47/EC?

Time is running out – ease your MDD compliance strategy stress with detailed guidance from a leading expert!

The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.

In this audio conference, our speaker provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.

Are You Ready for MDD Amendment Directive 2007/47/EC? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, January 27, 2010. For more details or to register, please visit our site at www.fxconferences.com

Brand Development and Enforcement Strategies

In uncertain economic times, it is vital that companies develop strong, identifiable, unique and protectable trademarks and brands. In this presentation, the speaker covers the entire range of brand development, including brand selection, trademark searching and counseling, international brand registration and brand expansion.

Brand owners must also protect against encroachment. This includes developing strategies to safeguard against improper importation of counterfeit or infringing merchandise, and knowing the steps that can be taken at the border to prevent it. Other enforcement targets discussed include counterfeiters operating at the local level; distributors, exporters and manufacturers operating up the commercial line; and infringers who do not directly copy a brand, but use marks likely to cause confusion. The presentation also covers brand development and enforcement over the Internet.

Brand Development and Enforcement Strategies was presented by Anthony F. Lo Cicero, Intellectual Property Attorney, with Amster Rothstein & Ebenstein LLP and aired on 2008-11-25. For more details or to download this event, please visit our site at www.fxconferences.com