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Highlights from last year's conference:

“Excellent forum to meet people from the industry and FDA in a relaxed setting.
Russ Davies, Vice President, Regulatory Affairs and Quality Systems, Smiths Medical, NA

“This conference was very enlightening, especially in trends regarding quality.
Bob Jaksih, Director of Technical Services, Perkins Electronics

...the FDA’s list of recalled devices that could pose serious health problems or death has grown over the last five years, with  18 so far this year...”. 

The Boston Globe, September 1, 2004


Session Descriptions:

Strategies to Prepare for and Survive an FDA Inspection

Mark Brown [BIO]
King & Spaulding, LLP

  • FDA's authority to conduct inspections
  • Understanding your rights
  • Knowing your responsibilities
  • Types of FDA's inspections
  • How to manage inspections and resolve disputes
  • How FDA's uses information collected during inspections
  • Potential consequences after an inspection
  • Inspection dos and don’ts

CE Marking for Medical Devices—Basic Steps to Compliance and Regulatory Update

Rene van de Zande [BIO]
President & CEO
Emergo Group

Hear a succinct overview and explanation of all relevant issues with regard to the European regulatory (CE Marking) medical devices requirements, including developing and managing Technical Files; labeling, risk management, vigilance and post-market surveillance, and quality management systems in accordance with ISO 13485:2003. Plus, get an update on the proposed amendments to the Medical Device Directive 93/42/EEC.

What's New in Europe?

Maarten Meulenbelt [BIO]
NautaDutilh, Brussels, Belgium

Product Liability: trends in product liability litigation in EU member states. Are courts getting stricter? How do QA and QA compliance affect the manufacturers' position?

Purchasing and Reimbursement Trends: prices of pharmaceutical product have been squeezed by central purchasing and national reimbursement systems. Are medical devices going the same way? What scope do national governments have to express preferences for particular brands or manufacturers? 

Trade and Distribution in an Enlarged EU. The enlargement of the EU from 15 to 25 countries in May 2004 has significantly affected trade in medical devices. A closer look at the impact of varying levels of patent protection, distribution systems and parallel imports

Better Safe Than Sorry: how the EC Court of Justice has been applying the "precautionary principle" regarding product approvals - and its impact on medical devices.

Interactive Roundtable Discussion:
Responding to 483s

Jim Kozick [BIO]
Principal Consultant
Regulatory and Compliance Services
PARAXEL Consulting

A brainstorming and problem solving session in which meeting participants are pre-assigned into groups of 8 to 10 executives. After initial instruction, each group works through a case study scenario on steps to take when a warning letter is received. The following topics are included in the lecture and roundtable discussions.

1.  Elements of a good 483 response
2.  Pitfalls to avoid when responding to 483s
3.  FDA's review process for 483 responses
4.  What to expect following a 483 response

Risk or Risky Management of Your Clinical Studies?

Charma Konnor
Senior Manager/ Consultant
Devices and Drugs
Phoenix Regulatory Associates, LTD

Risk Management is essential to the conduct and oversight of clinical studies.  Important components of risk management are study monitoring and auditing, to help achieve successful FDA review of your application.   Conversely, risky management can lead to data integrity problems and major hurdles to obtaining FDA approval.  FDA's Application Integrity Policy is explained, and examples of risky management and consequences are provided.

How to Gain Optimal Value from and Overcome the Inherent Problems of Internal Audits

Russ Davies
Regulatory Affairs and Quality Systems

Smiths Medical

Discover the inherent problems with treating internal quality system audits as ‘paperwork exercises’ only. Audits should challenge the internal systems and procedures against the regulatory requirements and best practices. It is important to get the information that you need from the audit process even though there may be barriers to achieving this.

Benefit from hearing Russ Davies cover various techniques and approaches that may be used to overcoming these types of issues, and enable the organization to use the audit process as an important management tool as part of its overall ‘health check’ process. Also learn strategies for auditing across a multi-site operation.

Measuring the Effectiveness of Your Quality System

Cecilia Kimberlin,  Ph.D. [BIO]
Group Vice President of Quality Assurance and Compliance, Medical Products Group
Abbott Laboratories

This presentation will address the challenges of evaluating current quality systems, redesigning them and implementing changes.  Walk away with knowledge on how to measure effectiveness and compliance.

More session abstracts coming soon...

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