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Session
Descriptions:
Strategies to Prepare for and Survive an FDA
Inspection
 Mark
Brown
[BIO]
Partner
King & Spaulding, LLP
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]
Partner
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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