| |
Ensuring
Compliance in Global Clinical Trials |
| |
Bruce
Wagman, Covance |
| |
|
| |
Best
Practices for Managing In-Country Translation Reviews |
| |
Andres
Heuberger, ForeignExchange Translations |
| |
|
| |
Managing
the Shift to Electronic Submissions
|
| |
Gina
Ross,
Beckloff Associates, a Cardinal Health Company |
| |
|
| |
The
New MDD: 14 Things You Need to Know |
| |
Dr.
Evangeline Loh, Emergo Group |
| |
|
| |
How
to Measure Quality in Clinical Translations |
| |
Andres
Heuberger & Jason Heaton, ForeignExchange Translations |
| |
|
| |
An
Overview of EMEA & Centralised Procedure |
| |
Dr.
Ulrich Granzer, Granzer Regulatory Consulting |
| |
|
| |
International
Sponsor/CRO Relationships: A Legal View |
| |
Maria
Buckley, Nutter, McClennen & Fish LLP |
| |
|
| |
Overcoming
Cultural Barriers to Global Marketing
|
| |
Nancy
Hoft,
Nancy Hoft Consulting |
| |
|
| |
The
Present and Future of SPL & PIM |
| |
Mark
Bayer & Gary Saner, Reed Technology |
| |
|
| |
Biologic
vs. Non-biologic: Current FDA Thinking on IVDs |
| |
Ann
Quinlan-Smith & Pamela Vaughan, Alquest, Inc. |
| |
|
| |
Best
Practices for Implementing ISO14971:2007
|
| |
Markus
Weber,
System Safety, Inc. |
| |
|
| |
Optimizing
Country Selection for Clinical Research
|
| |
Dr.
Susan Stansfield,
PRA International |
| |
|
| |
Maximizing
Productivity Among Spanish-Speaking Employees
|
| |
Melissa
Burkhardt, Futuro Sólido |
| |
|
| |
Monitoring
Essentials for International Device Trials
|
| |
Dr.
Helen Colquhoun, Pleiad Devices |
| |
|
| |
3
Steps to Successful Translation Management |
| |
Andres
Heuberger, ForeignExchange Translations |
| |
|
| |
The
"Why" and "How" of eCTD Conversion
|
| |
Gina
Ross, Beckloff
Associates |
| |
|
| |
Adapting
Patient Recruitment to Global Cultures
|
| |
Rob
Laurens &
Matt Stumm, BBK Worldwide |
| |
|
| |
Industry
Update: Vigilance for Medical Devices |
| |
Dr.
Evangeline Loh |
| |
|
| |
Regulation
vs. Communication: Finding the Balance |
| |
Ilyssa
Levins, HCIL Consulting |
| |
|
| |
Translation
& Linguistic Validation of PRO Measures
|
| |
Darren
Clayson, Pharmaquest Ltd |
| |
|
| |
Writing
& Designing for an International Audience
|
| |
Nancy
Hoft, Nancy Hoft Consulting |
| |
|
| |
Adaptive
Trial Design: Streamlining Clinical Supply
|
| |
Geert
Langendries, Covance |
| |
|
| |
Best
Practices for Creating & Translating Global Content
|
| |
Steve
Billings and Bill Rabkin,
Idiom Technologies |
| |
|
| |
Optimizing
CRA Deployment in Global Clinical Trials
|
| |
Marie
Snell, Covance |
| |
|
| |
Meeting
the Challenges of Global Oncology Trials
|
| |
Dr.
Ute Berger, PRA International |
| |
|
| |
Data
Management for Medical Device Trials: Best Practices |
| |
Helen
Colquhoun, Pleiad Devices |
| |
|
| |
How
to Mark and Label Devices Under IEC60601-1 3rd Edition |
| |
Leo
Eisner, Eisner Safety Consultants |
| |
|
| |
Bulletproofing
Personnel Policies Against Litigation
|
| |
Jay
R. Rush, PolicyTechnologies International |
| |
|
| |
Improving
Patient Safety with Proactive Re-supply Strategies
|
| |
Geert
Langendries, Covance |
| |
|
| |
IEC
60601 3rd Edition: Overview & Adoption Update
|
| |
Casey
Conry, UL |
| |
|
| |
EU
Device Labeling: Issues & Requirements |
| |
Dr.
Jaap Laufer, Emergo Group |
| |
|
| |
The
EU Paediatric Rule: What it Means for Pharma |
| |
Dr.
Ulrich Granzer, Granzer Regulatory Consulting |
| |
|
| |
Device
Advertising & the First Amendment
|
| |
Robert
J. Klepinski, Fredrikson & Byron |
| |
|
| |
Real-Time
Adverse Event Analysis Using IVR
|
| |
Hal
Ward, Covance |
| |
|
| |
Medical
Device and IVD Registration in China
|
| |
Janice
Ma, ChineGate Ltd. |
| |
|
|
Determining
Feasibility in Global Clinical Trials |
|
Kent
Thoelke, PRA International |
| |
|
| |
The
EU Perspective on Risk Management |
| |
Dr.
Stefan Blesse, Granzer Regulatory Consulting |
| |
|
| |
Improving
Clinical Development with Six Sigma |
| |
Tim
Strauss, Covance |
| |
|
| |
Clinical
Investigations in Asia |
| |
Edward
Ian, PRA International |
| |
|
| |
Best
Practices for Managing In-Country Reviews |
| |
Andres
Heuberger, ForeignExchange Translations |
| |
|
| |
Industry
Update: Vigilance for Medical Devices
|
| |
Rene
van de Zande, Emergo Group, Inc. |
| |
|
| |
Predicting
& Preventing Protocol Violations |
| |
Brett
Bishop, Covance |
| |
|
| |
Clinical
Development Opportunities in India |
| |
Nermeen
Varawalla, PRA International |
| |
|
| |
Best
Practices for Building Global eLearning Programs |
| |
Eoghan
O'Maolain, Rendition Digital |
| |
|
| |
Workflow/Version
Control: Taming the Documentation Tiger |
| |
Brian
Travis, Architag International |
| |
|
| |
Handle
With Care: Clinical Data Cleaning |
| |
Elaine
Job, Covance |
| |
|
| |
How
to Respond to FDA483s and Warning Letters |
| |
Alan
Schwartz, mdi Consultants |
| |
|
| |
Risk
Mitigation & Prevention in Real-Life Trials |
| |
Jill
Johnston, Covance |
| |
|
| |
CE
Marking: 7 Steps to Getting Started in Europe |
| |
Rene
van de Zande, Emergo Group |
| |
|
| |
Contracts:
Aligning Sponsor & CRO Interests |
| |
Lynn
Polgar, Covance |
| |
|
| |
Risk
Management Strategies: US vs. EU |
| |
Dr.
Stefan Blesse, Granzer Regulatory Consulting
Annette Stemhagen, United BioSource Corporation |
| |
|
| |
How
to Measure Quality in Clinical Translations |
| |
Andres
Heuberger, ForeignExchange Translations |
| |
|
| |
Industry
Update: Revisions to the MDD |
| |
Helen
Colquhoun, Pleiad Devices |
| |
|
| |
IEC60601
3rd Edition: Setting the Standard for Electromedical Devices |
| |
Harvey
Rudolph, UL |
| |
|
| |
Choosing
a CRO: Best Practices |
| |
Teresa
Ptaszynska, Covance |
| |
|
| |
3
Steps to Successfully Manage Clinical Translations |
| |
Andres
Heuberger, ForeignExchange Translations |
| |
|
| |
Indications:
The Next Battleground in FDA Advertising Enforcement |
| |
Robery
J. Klepinski, Fredrikson & Byron |
| |
|
| |
Protecting
Data Under Current EU Pharma Legislation |
| |
Ulrich
Granzer, Granzer Regulatory Consulting & Services |
| |
|
| |
Avoiding
the Top 20 Global Documentation Errors |
| |
John
Smart, Smart Communications |
| |
|
| |
Optimizing
RFPs: Simple Steps to Better Responses |
| |
Beth
Mandel, Covance |
| |
|
| |
State
of Readiness? XML in the Life Sciences |
| |
Don
Bridges, DCL & Joe Jenkins, RWD Technologies |
| |
|
| |
Clinical
Evaluations for Devices: the Literature Route |
| |
Helen
Colquhoun, Pleiad Devices |
| |
|
| |
How
to Evaluate Your RiskMAP |
| |
Annette
Stemhagen, United BioSource Corporation |
| |
|
| |
Conducting
Drug Trials in Latin America |
| |
Conchita
Delgado, Covance |
| |
|
| |
Using
Local Laboratories in Global Clinical Trials |
| |
Dr.
Jaap Dijkman, Covance Virtual Central Laboratory |
| |
|
| |
Monitoring
Essentials for International Device Trials |
| |
Dr.
Helen Colquhoun, Pleiad Devices |
| |
|
| |
EMEA
vs. Notified Bodies: Options for Combination Products |
| |
Phil
Brown, Quintiles Consulting |
| |
|
|
Device
Design in the Current Regulatory Climate |
|
Robert
J. Klepinski, Fredrikson & Byron |
| |
|
| |
How
to Write for a Global Audience |
| |
John
Smart, Smart Communications |
| |
|
| |
Conducting
Drug Trials in Asia Pacific |
| |
Helen
Ormandy, Covance |
| |
|
| |
The
Evolution of Risk Management |
| |
Annette
Stemhagen, United BioSource Corporation |
| |
|
| |
SPL
& Beyond: XML in the Life Sciences |
| |
Don
Bridges, DCL and Joe Jenkins, RWD |
| |
|
| |
Conducting
Drug Trials in Central & Eastern Europe |
| |
Malgorzata
Szerszeniewska, Covance |
| |
|
| |
New
EU Rules for Engineered Tissue Products |
| |
Thierry
Chignon, Director, Quintiles Consulting Europe |
| |
|
| |
The
Revised MDD: Practical Implications for Devices |
| |
Helen
Colquhoun, CEO, Pleiad Devices |
| |
|
| |
Developing
Software for Global Markets |
| |
Adam
Asnes, President, LingoPort |
| |
|
| |
Japan's
PAL: What Device Companies Need to Know |
| |
Steve
McRoberts, Global Principal Engineer, UL |
| |
|
| |
A
Guide to Efficient Translation Management |
| |
Angelika
Zerfass, Translation Tools Consultant |
| |
|
| |
Industry
Update: Revisions to the MDD |
| |
Dr.
Thierry Chignon, Quintiles Consulting Europe |
| |
|
| |
Risk
Management for Opioid Products |
| |
Dr.
Edgar Adams, Covance |
| |
|
| |
Meeting
FDA Requirements for Structured Product Labeling |
| |
Don
Bridges, Data Conversion Laboratory |
| |
|
| |
How
to Profit From Your Translation Memory |
| |
Jost
Zetzsche, TM Marketplace |
| |
|
| |
21
Steps to Easier Globalization through Better Writing |
| |
John
Smart, Managing Partner, SMART Communications |
| |
|
| |
Changing
Policies for Hospital Outpatient Reimbursement |
| |
John
Carlsen & John Siracusa
Covance Market Access Services |
| |
|
| |
What
You Need to Know to Get Started in XML |
| |
M.
Katherine Brown, Principal, Comgenesis LLC |
| |
|
| |
Medicare
Update: Understanding the CAP |
| |
John
Carlsen, Principal, Covance Market Access Services |
| |
|
| |
Challenges
Encountered & Lessons Learned in the New EU
|
| |
Karen
Howes, Director of Regulatory Affairs
European Diagnostics Manufacturers Association |
| |
|
| |
What
You Might Not Know About Part D & Medicare Advantage |
| |
John
McDermott, VP, Covance Market Access Services |
| |
|
| |
Writing
for Translation: The 1% Solution |
| |
John
Smart, President, SMART Communications |
| |
|
| |
Medical
Device Clinical Evaluations: EU vs. US |
| |
Helen
Colquhoun, CEO, Pleiad Devices |
| |
|
| |
How
to Choose Your Translation Vendor |
| |
Kit
Brown, Comgenesis LLC |
| |
|
| |
An
Introduction to Translation Memory Technology
|
| |
Angelika
Zerfass, Translation Tools Consultant |
| |
|
| |
Global
Unifying Trends in Device Regulation |
| |
Harvey
Rudolph, Global Program Manager,
Underwriters
Laboratories
|
| |
|
| |
Alternative
Site Selection: China |
| |
Brett
Bishop, Covance |
| |
|
| |
Best
Practices for Medical Device Design |
| |
David
West, VP, Quintiles Consulting |
| |
|
| |
Moving
Target: Animal Tissue Regs Update |
| |
Phil
Brown, Quintiles Consulting |
| |
|
| |
Getting
Your Tissue Products Ready for 2006 |
| |
Phil
Brown, Quintiles Consulting |
| |
|
| |
The
FDA & Risk Management for Biopharm Sponsors |
| |
Annette
Stemhagen, Covance |
| |
|
| |
Navigating
the EU Human Tissue Maze |
| |
Phil
Brown, Quintiles Consulting |
| |
|
| |
Vigilance
for Device Manufacturers: EU vs. US |
| |
Helen
Colquhoun, CEO, Pleiad Devices |
| |
|
| |
The
Case for Value-Based Content Management |
| |
Ben
Martin, Industrial Wisdom |
| |
|
| |
The
Benefits of Risk Management |
| |
Harvey
Rudolph, Global Program Manager
Underwriters Laboratories |
| |
|
| |
Effective
Risk Management: The Cost of Prevention? |
| |
Rob
Davie, VP, Covance Europe |
| |
|
| |
The
New Europe: Overview for Device Manufacturers |
| |
Mika
Reinikainen, VP, Quintiles Europe |
| |
|
| |
Asian
Clinical Trials: What to Know Before You Go |
| |
Anthony
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