Best Practice In Phase IV Clinical And Observational Research Conference 3-4th Dec 09 Prague

Main Category: Conferences
Also Included In: Clinical Trials / Drug Trials
Article Date: 04 Sep 2009 - 0:00 PDT

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Phase IV clinical trials are one the fastest growing areas of clinical research. Such post-marketing studies are becoming increasingly important as regulatory agencies demand more long-term data which proves efficacy, safety and quality. Furthermore, a key driver is the demands of health technology assessors and payers and their need for evidence-based economic data, again over the long-term. However, as post-marketing studies tend to be more commercial in nature, successfully planning and implementing them can be a major challenge, especially in terms of motivating investigators and recruiting patients who may already have access to the latest medications.

This event will be looking moving towards "best-practice" approaches to designing and implementing post-marketing studies. Essential topics to be discussed will include:

• Study design considerations and implications
• Comparative studies
• Balancing the complex requirements of key stakeholders: marketing, clinical, regulatory, safety, KOLs and investigators
• Overcoming patient recruitment and retention challenges, when the product is commercially available
• Motivating academically - focused investigators for commercially-focused studies
• Finding and performance managing the right CRO
• Leveraging phase IV clinical research to maximise product life cycles
• Best practice approaches in phase IV clinical operations and implementation
• Outsourcing phase IV & observational studies

Why attend:

• Gain access to the latest methodologies and real-life cases in the field
• Explore how market leaders are improving data accuracy
• Balancing conflicting scientific, regulatory & marketing needs
• Learn more about comparative studies and their value for drug safety
• Understand how key figures are affecting future trends and standards
• Meet ethics committees to retrieve the full regulatory / ethical picture
• Find out how phase IV studies & observational research are being outsourced and how industry players are selecting the right partners

Who will benefit:

Pharmaceutical & biotech companies
Vice Presidents, Directors & Managers of: Medical Affairs, Epidemiology, Clinical Development & Operations, Drug Safety, Pharmacovigilance, Data Management, Regulatory Affairs, Clinical Outsourcing Solution providers
CROs, EDC & Data Management, Clinical Software, Market Access & Health Outcomes Consultancies Academics & doctors
Epidemiology, Principle Investigators, Primary Care
Government
Ministries of Health, Regulatory & Health Technology Assessment Agencies

To request the full agenda please click here.

For Booking Information:
Tel: +421 232 660 382
Fax: +421 232 660 397
Email: erika@nextlevelpharma.com

Source:
Erika Vavrovicova
NextLevel Pharma

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