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6th Annual European Medical Device Clinical Research Conference



 
Our Price: $395.00

Product Code: 2150
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As the number of medical device clinical research studies being conducted throughout Europe continues to rise, innovative and forward thinking manufacturers are developing and implementing advanced strategies aimed at reducing overall clinical research time-frames, as well as limiting and reigning in costs. In this environment where great regulatory scrutiny plays a role at every step of product development, and patients are becoming increasingly savvy at researching and understanding their importance to the study, clinical executives need an opportunity to engage with their peers and recognize the forward-thinking strategies of leading organizations. The Q1 6th Annual European Medical Device Clinical Research Conference provided a platform for education and knowledge share, focusing on the cutting-edge strategies and methods being used throughout the industry to overcome patient recruitment and retention challenges, site-selection and management tools that optimize time and budget, as well as provided clarity as Medical Device Directives recently released evolve into Regulation, and the impact this will have on the industry and clinical research goals.

KEY CONFERENCE TAKEAWAYS
  • Insight on Clinical Budget Planning
  • In Depth Focus On MDD Becoming MDR and the Impact on Clinical Operations
  • Competent Authority (IMB Ireland) Perspective of Regulatory Changes
  • Fresh Ideas and Methods to Enhance Patient Recruitment & Retention
  • New Topic of Interest: Investigator Protocol Adherence and Compliance
  • Expediting Multi-Country Trial Approval Process
  • Contracting With Study Site: Key Considerations
  • Insight on Post-Market Studies: Focus On Management & Evidence Generation

PRODUCT INFORMATION:
Presentations slides are in PDF. format
All files are available for immediate download.

INCLUDES THESE PRESENTATIONS:

SUCCESSFULLY PLANNING STUDY SITE BUDGETS
Dorothee Arenz, Deputy Head of Medical Division
CLINICAL TRIALS CENTER (ZKS KÖLN), COLOGNE UNIVERSITY

DECREASING APPROVAL TIMELINES FOR MULTI-COUNTRY STUDIES
Sharon Herbert, Medical Research Manager
NAMSA

TRAINING CLINICAL SITE PERSONNEL TO SECURE A SMOOTH & EFFICIENT TRIAL
Mark Ver Heyen, Manager Clinical Research BENELUX
BIOTRONIK

MDD TRANSITIONING TO MDR: UNDERSTANDING THE IMPACT ON EUROPEAN CLINICAL OPERATIONS
UPDATED REQUIREMENTS & IMPACT ON CLINICAL

Philippe Auclair, Sr. Director, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory EMEA
ABBOTT LABORATORIES

POST MARKET SURVEILLANCE + ADVERSE EVENT HANDLING
Heike Wachenhausen, Attorney at Law
WACHENHAUSEN RECHTSANWÄLTE

HEALTH AUTHORITY PERSPECTIVE
Paul Scannell, Pre-Market Evaluation Officer, Human Products Authorisation & Registration
IRISH MEDECINES BOARD

NOTIFIED BODY EXPECTATIONS
Sabine Ohse, Director of Healthcare Operations
BSI

CASE STUDY: PROACTIVELY UPDATING INTERNAL CLINICAL STRATEGIES TO MEET NEW REGULATIONS

Gudrun Denke, Deputy Dir. Clinical & Preclinical Research & Development
GEISTLICH PHARMA

ACCELERATING OPERATIONS THROUGH INTERNAL TEAM COLLABORATIONS
Victoria Cavendish, Senior Director, Medical Devices and Diagnostics
DTARGET

PATIENT RECRUITMENT AND MANAGEMENT: CREATIVE METHODS TO MEET TARGETS
Florian Ludwig, International Director Clinical Affairs
COVIDIEN

Roland Preisach, Senior Technical Field Specialist
COVIDIEN

GROUP DISCUSSION: OPTIMIZING HCP STUDY PROTOCOL ADHERENCE & COMPLIANCE
Ihsen Merioua, Director THV Clinical Programs
EDWARDS LIFESCIENCES

EFFECTIVELY PERFORMING MEDICAL DEVICE POST-MARKETING STUDIES IN EUROPE
Vytis Jusevicius, Project Director, Project Management
APTIV SOLUTIONS

EXAMINING THE NEW EUROPEAN PATIENT DATA PROTECTION REGULATION
Jörg Hladjk, Counsel
HUNTON & WILLIAMS

Johannes Jördens, Associate
HUNTON & WILLIAMS

ETHICON CASE STUDY: POST-MARKETING EVIDENCE GENERATION FOR GASTRIC BAND IN MORBID OBESE PATIENTS
Goran Ribaric, Head of Clinical & Medical Affairs EMEA
ETHICON ENDO-SURGERY

OPPORTUNITIES IN WORKING WITH CLINICAL RESEARCH NETWORKS TO ENHANCE TRIAL MANAGEMENT
Divya Chadha Manek, Industry Business Development Manager
NIHR CLINICAL RESEARCH NETWORK (NIHR CRN)



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