Kendle Experts Comment on Key Issues Regarding Drug Safety and Risk Management at the FDA Regulatory and Compliance Symposium at Harvard University
Posted on: Friday, 26 August 2005, 15:01 CDT
CINCINNATI, Aug. 26 /PRNewswire-FirstCall/ -- Recent high-profile recalls of widely prescribed medications have spotlighted the need for more thorough testing and increased long-term safety surveillance studies to monitor the potential risk of a new drug to the population. With the recent establishment of the Drug Safety Oversight Board within the FDA, biopharmaceutical companies face more rigorous postmarketing commitments and higher safety standards than ever before, creating significant opportunities for CROs with expertise in safety studies of approved products as well as regulatory risk management during development.
(Logo: http://www.newscom.com/cgi-bin/prnh/20030429/KNDLLOGO )
Four experts from Kendle , a leading, global full-service clinical research organization, spoke at the FDA Regulatory and Compliance Symposium: Managing Risks -- From Pipeline to Patient and addressed these issues as well as how CROs help their pharmaceutical partners ensure compliance in this environment of heightened regulatory scrutiny. Kendle experts participating in the symposium included:
-- William K. Sietsema, PhD, Vice President, Clinical and Regulatory Strategic Planning Sietsema presented Managing Your Product Pipeline in this New Era of FDA Scrutiny. The presentation focused on balancing pipeline portfolios and development risks, the shifting of the market from targeted to personalized medicine, and pipeline management in a post- Vioxx(TM) world. Sietsema is the author of the book Strategic Clinical Development Planning: Designing Programs for Winning Products. -- Cynthia L. Verst-Brasch, PharmD, MS, Vice President, Late Phase Verst-Brasch spoke about the increase in the number of postmarketing commitments (PMCs) and creative and scientifically rigorous approaches for these studies as part of her presentation Best Practices in Meeting Your Postmarketing Study Commitments. -- Kenneth Hintze, PhD, Director, Global Safety and Pharmacovigilance Hintze co-presented Risk Management Case Study: The RADARS(R) System with J. David Haddox, DDS, MD of Purdue Pharma L.P. The presentation reviewed the innovative surveillance program, which is examining the nature and extent of abuse of scheduled prescription opioid medications. Hintze detailed Kendle's methodology for the study and discussed the real-world challenges and solutions in developing good risk management programs. -- Anthony C. Celeste, Senior Vice President, Regulatory Affairs Celeste's presentation cGMP: Good for Business but Who is Enforcing Who? addressed the importance of developing Good Manufacturing Practices (GMPs) and the challenges of meshing those practices with FDA regulations and oversight.
With drug safety fueling an unprecedented number of legislative and regulatory changes by FDA and Congress, the approval and ongoing compliance of new drug products will become even more complex. Kendle can assist biopharmaceutical companies in navigating through this environment of regulatory complexity to gain approval and maintain compliance of their marketed products.
The Kendle presentations from the FDA Regulatory and Compliance Symposium may be viewed at http://www.kendle.com/industry_events/industry_events_pp.php . For more information or to contact one of the speakers, please call Lori Dorer in Kendle Corporate Communications at (513) 345-1685.
About Kendle
Kendle International Inc. is among the world's leading global clinical research organizations. We deliver innovative and robust clinical development solutions -- from first-in-human studies through market launch and surveillance -- to help the world's biopharmaceutical companies maximize product life cycles and grow market share. With the expertise of our more than 1,800 associates worldwide, Kendle has conducted clinical trials or provided regulatory, pharmacovigilance and validation services in 70 countries. Investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202, or from the company's Web site at http://www.kendle.com/ .
Photo: http://www.newscom.com/cgi-bin/prnh/20030429/KNDLLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.com
Kendle International Inc.
CONTACT: Patty Frank, Investors, +1-513-763-1992, or Lori Dorer, Media,+1-513-345-1685, both of Kendle International Inc.
Web site: http://www.kendle.com/http://www.kendle.com/industry_events/industry_events_pp.php
Source: PRNewswire-FirstCall
Related Articles
- FDA Shifts to Pre-Empting Drug Risks as REMS Program Reaches 'Terrible 2s'
- Affymetrix Announces New Cost-Effective Product for Standardizing Drug Metabolism Studies
- Medtronic Starts U.S. Arm of Global Study Comparing Safety of Endeavor(R) and Cypher(R) Drug-Eluting Stents
- FDA Warns of Ultrasound Drug Risks
- US FDA Grants Immtech's Oral Drug Candidate Pafuramidine (DB289) Orphan Drug Status for Treatment of PCP
- Nektar Announces That U.S. FDA Has Granted Orphan Drug Designation to the First Amphotericin B Inhalation Powder to Prevent Pulmonary Fungal Infections in Immunosuppressed Patients
- FDA Strengthens Warning on Drug Paxil
- Scientists Plan Huge Painkiller Risk Study
- Pregnant Women Not Using Acne Drug Properly: Study
- Research and Markets: Molecular Biomarkers for Clinical Diagnostics and Drug Discovery and Development
 |
 |
User Comments (0)
RSS Feeds