2nd Clinical Trials Inspection Readiness Summit

Back by popular demand, we are delighted to present the 2nd Annual Clinical Trials Inspection Readiness Summit. The goal of this conference is to evaluate the necessary steps that sponsoring companies must take in order to ensure that their clinical investigator sites remain compliant before and during an agency inspection to avoid serious fine and penalties. In addition, the importance of conducting internal audits and opening up the lines of communication between the investigators and the sponsoring company will also be explored, both locally and globally.

Gain a crystal clear understanding of what to expect from various agencies around the world during an inspection, and how to improve the efficiency of your organization’s internal processes to ensure you are inspection-ready. Our intention for this meeting is not only to educate by sharing lessons learned by industry speakers who have "been there, done that", but also to provide a welcoming forum in which the audience will interact, be engaged, and network with those who are in the know. Delegates will leave the event armed with best practices, useful new tools, a better understanding of what health authorities command, and confidence to bring potential, successful, SOPs to the table within their own organizations.

TOP FIVE REASONS TO ATTEND

  1. The FDA/EMA/MHRA will share what they are looking for during an inspection to remain compliant
  2. Only conference in the industry that is exclusively GCP-focused rather than GMP regarding inspection preparation
  3. Provides industry leaders with proactive strategies shared through case studies designed to prepare their investigators for an inspection throughout an entire clinical trial
  4. Presenters knowledgeable in European and Latin American regulatory requirements will present on working in alignment with the FDA
  5. CROs will share procedural tips on how to prepare sites for auditors

Who Should Attend

C-Level, Vice President, Director, and Manager level executives from pharmaceutical, biotech, medical device companies, and CROs in the following areas

  • Clinical Quality Assurance
  • Clinical Quality Control
  • Clinical Quality Compliance
  • Global Compliance
  • Global Quality Management
  • Clinical Operations & Affairs
  • Clinical Monitoring
  • Clinical Research
  • Safety & Risk Management/Operations
  • Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Trials
  • Clinical Development
  • Clinical Document Coordinator
  • Clinical Site Management
  • Global Regulatory Affairs

This conference is also relevant to clinical QA/compliance professionals involved with

  • CROs
  • IRBs
  • Investigative Sites
  • Data Management/Computer Software
  • Consulting Firms

Attendees by Company Profile

Attendees by Level