Clinical Regulatory - Pack of 11 Webinars

Agenda:

• Definition of Good Clinical Practice
• Provide a historical perspective on GCP
• Why do we need GCP?
• 13 core principles of GCP
• Introduction to ICH E6
• Review of ICH E6 (R3) Latest Guidance
• How to implement GCP in your organization

• Define clinical research essential documentation
• Review the GCP requirements for essential documents
• Determine essential subject and non-subject specific documentation requirements per trial
• Discuss essential documentation for drugs, biologics and devices
• Describe the significance of document management in clinical research
• Learn how to set up, maintain and manage a document system that meets regulatory standards
• Understand the role of auditors, and learn how to archive documentation and prepare for a   quality assurance (QA) audit or regulatory inspection
• Prepare for regulatory inspection: Proactive and reactive use of essential documentation

Agenda:

The webinar will begin with a regulatory overview of sponsor responsibilities This will be followed by explanation on how to choose the right vendor. Finally, Best Practices for creating, implementing and maintaining tools to ensure the correct vendor is chosen for the sponsor requirements.

• What do the Regulations mean?
• Vendor oversight - Where do you start?
• Vendor management as a team approach
• Defining requirements
• Quality insight and input
• Pre-Qualification of a vendor
• Use of Tools and Processes
• Managing vendor performance

FDA’s GMP Expectations for Phase I and First-In-Man Clinical Trials

Agenda:

• FDA Regulations and Guidance Documents for Phase I clinical trials
• Key Elements and Best Practices of GMP for Phase I clinical trials
• IND content and format for CMC information
• Vendor Selection and Management for outsourcing early manufacturing
• Raw Material selections and considerations

• Identify and manage risks of clinical trials
• Perform Cause-Effect Analysis for identified risks and develop mitigation strategy
• Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
• Develop effective Corrective Action Preventive Action (CAPA) Plans

TOPIC 6

GCP Compliance - Audit Preparation and Inspection Readiness

• Define key GCP elements
• Identify the universal components of GCP
• Explain the differences between the legal and procedural elements of GCP
• Recognize key differences in GCP for drug, device, and biologics
• Describe the overlap between GCP, GLP and GMP
• Risk-Based Auditing: Applying risk assessment and management principles to clinical quality assurance
• Describe the key principles of Six Sigma for process improvement and Quality by Design (QbD)
• Develop relevant metrics as quality and key risk indicators (KRIs) for Risk-Based Quality Management (RBQM) systems to proactively identify and mitigate risk
• Quality Management Systems: Program design and implementation
• Describe the elements of a functional quality system
• Develop and implement site-specific approaches for corrective action of non-compliance
• Examine recent trends in non-compliance
• Regulatory Trends: Review of recent FDA findings for Sponsors, CROs, Monitors, IRBs, and Sites
• Auditing Clinical Research Organizations (CROs) through Qualification, Selection, and Ongoing Oversight
• Auditing Technology Providers, Site Management Organizations (SMOs), and Other Partners
• Responding to Audit Observations with your third party vendor
• Achieving “GCP Inspection Readiness”: Preparation, Process, and Ongoing Preparedness
• GCP Compliance with Standard Operating Procedures (SOPs): Development, Implementation, and Management
• Ensuring site compliance and managing noncompliance, including Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) for sites
• Performing mock audits to identify strengths and address weaknesses
• Auditing sites for fraud, bioethics, or serious noncompliance

How to Best Document Clinical Evaluation Report (CER) for CE Mark

• Applicable Laws
• Definitions
• CE Marking
• Clinical Evaluation Requirements
• Clinical Evaluation: Format and Contents
• Key Considerations
• Common Mistakes
• PASS-IT Recommendations for Best Practices: Dos and Don’ts

Clinical Project Management

• Regulatory requirements for clinical trial management
• Legal considerations
• Elements to consider in setting up and managing clinical trials
• Formats and essential components of SOPs for CTM
• SOP training and implementation
• Systems to assist in CTM
• Vendor selection oversight

Successful FDA Meeting Preparation and Conduct

• Standard FDA Meeting Types and Timing
• General Qualifying Requirements
• Preparing the Meeting Request
• Preparing the Briefing Document
• Rehearsing for the Meeting
• Conduct of the Meeting
• Post-Meeting follow up
• Non-typical FDA meetings
• Preparation for non-typical meetings
• Documenting Informal meetings and correspondence
• Reference to meetings during future submissions

Medical Device Clinical Investigations to the new EU MDR Requirements

• Overview of the new MDR expectations from clinical investigations
• Intersection with GDPR
• Intersection with the “clinical evaluation process”

EU's New Regulation 535/2014 on Clinical Trials - Insights into Effective Clinical Trials

• Clinical trial basis
• Participant safety issues
• EU's New Regulation 535/2014 on Clinical Trials
• Roles and responsibilities
• Documentation requirements: Before, during, and after
• Trial administration
• Key steps in the clinical trial
• Deliverables.
• Subject safety