Pre-IDE Submissions and Meetings: Best Practices

Companies that develop medical devices today have the option of informally meeting with the FDA staff in what is called a "pre-IDE meeting." This meeting will ultimately review their marking application in order to gain clarity about the agency’s expectations regarding the preclinical and clinical testing requirements for their device. In most cases, it is critical to take advantage of this opportunity.

This presentation describes how to optimize the pre-IDE submission of information to FDA, as well as the meeting that follows this submission, in order to maximize the information derived and facilitate your device development plan.

Pre-IDE Submissions and Meetings: Best Practices is being presented by Dr. Elisa Harvey, Senior Regulatory Consultant, with CardioMed Device Consultants and airs on Wednesday, May 20, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Partnering with the New e-Patient for Recruitment Success

The Internet has changed the way people approach their own health care, creating a new breed of engaged, empowered consumer known as the ‘e-patient’. They are taking charge of finding information about their diagnoses and treatment options, and they aren’t shy about interacting online with other patients to exchange experiences and learn more. The most active searchers, according to a groundbreaking white paper by Dr. Tom Ferguson and the e-Patients Scholars Working Group, are acute (newly diagnosed) and chronic patients – arguably, the optimal candidates for clinical trial participation.

This conference profiles the new e-patient, offers strategies for getting his/her attention, and assesses the benefits and challenges of partnering with this population to optimize clinical trial participation.

Partnering with the New e-Patient for Recruitment Success is being presented by Rob Laurens & Matt Stumm, with BBK Worldwide and airs on Thursday, April 23, 2009. For more details, or to signup for this event, please visit our site at www.fxconferences.com

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside

New Chemical Entities (NCEs) that increase the percentage of sustained viral response with current standard treatment for hepatitis C have great marketing potential. Protease inhibitors, polymerase inhibitors, interferons, enzyme inhibitors, viral entry blockers, TLR agonists and oligonucleotides all seek to be included in the future armamentarium. Whether these different classes of compounds can fit together and lead to a successful combination treatment is still unknown. Registration of these NCEs is a long and arduous path, with no guarantee of success.

Drawing on his expertise and 19 years of experience, in this audio conference Dr. van Vliet provides an inside look at opportunities and obstacles when developing a hepatitis C compound, and discusses the critical steps necessary to optimize the chances of the NCE -- condensed Phase I development programs, subsequent proof of concept studies to verify efficacy, and competition for patients versus Phase III trials.

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside is being presented by Dr. Andre van Vliet, Vice President of Medical Affairs, Early Development Services, with PRA International and airs on Tuesday, April 14, 2009. For more details or to register, please visit our site at www.fxconferences.com

Lifecycle Management of the eCTD and NeeS in Europe

With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a sponsor file individual submissions or combined submissions for the Reference Member State (RMS) and the Concerned Member States (CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions (NeeS)? What is the time line for all Reference Member States to accept eCTD submissions? In addition to the challenges of choosing the appropriate filing procedure, Sponsor organizations must also understand the concept of life cycle management for the eCTD and NeeS submissions. Unlike FDA, EU has specific requirements for tracking the submission life cycle management approach in Module 1, and the approach for lifecycle management is dependent upon which filing procedure has been selected.

Understanding what information needs to be provided to the RMS and CMS also represents unique challenges for the eCTD life cycle management. For sponsor organizations considering global submissions, the significance of understanding eCTD life cycle management is critical to ensuring a successful and smooth submission process.

Lifecycle Management of the eCTD and NeeS in Europe is being presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates and airs on Tuesday, April 21, 2009. For more details or to register, please visit our site at www.fxconferences.com

Overcoming Challenges in Clinical Cold Chain Transport

Global transport of temperature-sensitive investigational drugs and clinical materials presents a tremendous challenge for pharmaceutical and biotech companies. There are many factors to consider in order to ensure that product integrity remains intact. Successful delivery of investigational drugs from origin to patient is becoming more complicated, especially with increased scrutiny placed on in-transit temperature control and monitoring. As cold chain shipment excursions face increased scrutiny from regulators around the world, it is more important than ever to get it right the first time.

In this audio conference, the speakers review the areas that need to be considered by the clinical development community in order to maximize the performance of their cold chain R&D investments.

Overcoming Challenges in Clinical Cold Chain Transport is being presented by Anthony Leone & Les Sparrow, International Customer Service Manager, Quality Assurance & Technical Support Manager, with World Courier, Inc. and airs on Tuesday, May 12, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com