Hear from top industry and regulatory experts, including:

Improving Quality and GCP Standards through Understanding Regulatory Expectations and Achieving a Risk Based Approach to Auditing and Inspection Preparation

A staggering 20% of all clinical trials are now subject to regulatory audits, and inspectors’ expectations are continually evolving. With an increasing number of regulatory warnings, relating to record keeping and informed consent, it is more crucial than ever to comply with GCP and be inspection ready.

Pharma IQ is pleased to announce Europe’s leading, dedicated GCP, Auditing and Compliance conference taking place on 30th November - 1st December 2010. The event will provide you with a unique opportunity to gain insight from 17 GCP, regulatory, risk management and record management pioneers, share their inspection experiences and take the next steps to securing first time approval.

Many organisations and regulatory agencies are adopting quality based risk models to drive efficiency when auditing multiple sites and the GCP, Auditing and Compliance conference will provide with the most case studies and learning platforms to address this with five of the industry’s leading experts who have successfully developed and implemented these models.

Download the brochure here for more details.

Benefits of attending

  • Explore the new constantly evolving regulatory expectations and exceed inspection criteria across all sites and trials
  • Harness the time-saving potential of developing quality based risk models when planning internal audits and ensure you are auditing the most suitable sites, studies and countries
  • Improve your proficiency in data record management and obtain a thorough document audit trail to avoid regulatory warnings and get first time approval
  • Evaluate and discuss industry feedback on the Clinical Trials Directive public consultation paper and explore the future development of the directive and its potential impact
  • Implement detection and escalation strategies to cement relationships and strengthening communication with your CRO
  • Investigate the ethical and GCP considerations when running non-interventional studies clinical trials in emerging countries

What the event will discuss

  • Regulatory expectations in a bid to maintain compliance
  • Promoting standardisation and harmonisation between regulators
  • Improving efficiency and saving costs through developing strategic risk models
  • Ensuring compliance with GCP in clinical trials performed in emerging markets
  • Evaluating the potential impact of the new Clinical Trials Directive
  • Achieving comprehensive record and data management and ensuring a thorough audit trail
  • Optimise communication with your CRO to ensure a successful trial and audits

TESTIMONIALS

Past Pharma IQ delegates comments:

Great mix of presenters covering a comprehensive range of topics – well done. Superb networking opportunity
Pfizer
Interesting & willing to create discussion and to elaborate the presented themes. It was valuable.
Hovione Farmaciencia SA
Media Partners
Media Partners

[ Register Now ]