Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971.

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 aired on 2008-02-21 and is available for download at www.fxconferences.com

Complying with EU Antitrust Laws

It is vital that any company doing business in Europe be aware of existing antitrust provisions, and perhaps especially important for those in the life sciences. This presentation gives a general overview of EU antitrust law, and highlights those areas of particular relevance to medical device and pharmaceutical companies. The presentation places added emphasis on identifying special areas of risk, such as agreements restricting competition, information sharing between competitors, distribution agreements and abuse of market-dominating positions. Our speakers will also discuss when you should seek legal assistance, and how to behave in the event of dawn raids.

Complying with EU Antitrust Laws is being presented by Marc Besen & Dr. Christian Mayer, Partner & Associate, Clifford Chance and airs on Tuesday, March 10th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Dealing with Conflict of Interest in Troubled Economic Times

We need look no further than the morning paper to see charges or allegations of conflict of interest involving high-profile people and organizations. However, the fact of the matter is that in the business world, situations arise almost every day where there exists the potential for conflict. How best to handle them?

In this audio conference, our speakers will help the audience understand and adjust to changing standards regarding ethical business behavior and potential conflicts of interest. The presentation will discuss both the visible and less-than-visible types of conflicts of interest that business people confront in their roles as executives, directors, advocates and advisors. Using examples torn from recent headlines, the speakers will illustrate methods of coping with those conflicts, and explain the importance of developing a personal and professional code of ethics. They will also discuss some recent and ongoing academic research on governance and ethics, and explore both domestic and international efforts to cope with conflicts.

Dealing with Conflict of Interest in Troubled Economic Times is being presented by Michael Martorelli & Patricia Connolly, Director, Fairmount Partners & Managing Director, LeBow College of Business and airs on Thursday, March 5th, 2009. For more details or to register, please visit our site www.fxconferences.com

Managing Global Market Research for Consistency and Insight

Medical companies are increasingly sponsoring global research projects – but is this research effective? How can cultural and linguistic differences be managed to ensure the integrity of the result? Are differences between cultures just skin deep or do they extend to personality? How can we create research metrics that will have consistent meaning around the world? In this Webinar we will provide understanding of these issues and tools for managing global research projects.

Managing Global Market Research for Consistency and Insight was presented by Peter Simpson, President, with Segmedica and aired on 2008-11-12. For more details or to purchase the recording of this event, please visit our site www.fxconferences.com

The Pre-IND Program: 12 Steps to a Successful IND Filing

The Pre-IND phase of drug development is the foundation upon which all subsequent IND research depends, in order to obtain FDA market approval (NDA) after completion of required Phase 1-3 trials. Therefore, it is essential to give proper forethought and attention to these first, all-important steps. This audio conference looks at the 12 essential steps to complete during the Pre-IND phase of development leading to the filing of an original IND with the goal of obtaining FDA approval for initial Phase 1 clinical trials.

Our speaker, veteran industry expert Dr. Larry Hofmann, will give expert guidance on the optimum background and make-up of your pre-IND development team. He will also discuss strategic planning for and preparation of the FDA meeting information package -- provided to the FDA reviewing division 30 days prior to the pre-IND meeting -- which must include available pharmacology and toxicology summaries, as well as a summary of CMC data on the IND clinical formulation to support the proposed Phase 1 and Phase 2a study protocols.

The Pre-IND Program: 12 Steps to a Successful IND Filing is being presented by Dr. Larry Hofmann, President, with LMH Associates, Inc. and airs on Tuesday, March 31th, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.