Thursday June 22nd, 2017 to
Friday June 23rd, 2017,
9:00 AM to 6:00 PM
The LaLiT Mumbai
Sahar Airport Road, Andheri East, 400059,
Course "Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
• Defining the basic requirements of Good Clinical Practices
• Clinical Study Protocol Elements and Device Accountability
• Role of Institutional Review Board (IRB) and Informed Consent • Principles of Ethics and Quality Control
• Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial
• Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials
• Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection
• Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials • And Much More... Why should you attend?
• What is GCP and why is it needed?
• History and development of GCP in EU and US and where are we now?
• Managing problem areas of working with GCP regulations and guidelines • Impact of GCP globally and key FDA differences
• Recognize the regulatory pathways in the U.S
• Explore practical aspects of investigator and monitor selection
• Discuss how to comply with the fundamentals of Good Clinical Practice (GCP)
• Examine practical aspects of conducting international clinical trials
• Understand the significance of Ethics and Human Subject Protection
• Understand how to prepare for audit and inspection of clinical trials • Recognize what prompts an FDA audit
• Learn how to plan for an audit or inspection, including using appropriate checklists • Appreciate how to prepare for audit/inspection Interviews
• Consider how to respond to the audit/inspection findings • How to monitor clinical trials effectively and efficiently
• Comprehensive overview of the applicable regulations on good clinical practice and clinical trials • Attendees are encouraged to discuss GCP work related activities associated with their functional area on the various topics as applicable for interactive group discussion
• Review and discuss pain points, challenges and solutions Areas Covered in the Session:
• Adherence to ethical principles as laid out by the Helsinki Declaration
• Good Clinical Practice regulations require that clinical trials be consistent with regulatory requirements
• Good Clinical Practice regulations require the sponsor to make available clinical and nonclinical data from the study to support further related research
• Trials should thoroughly assess the risks and benefits inherent in a clinical research
• The clinical research should ensure the wellbeing of its subjects
• Good Clinical Practice regulations require sponsors of a clinical trial to contain a clearly defined protocol that should be rooted in established scientific principles and practices
• A clinical research program must be subject to oversight from an independent Ethics Committee • Good Clinical Practice regulations requires the sponsor to obtain informed consent from each of the subjects
• Good Clinical Practice regulations requires adherence to set documentation practices
• There should be thorough confidentiality of information relating to the subject
• The adherence to applicable Good Manufacturing Practices (GMP) by the sponsors when it comes to the manufacture, storing and handling of investigational products is another requirement of Good Clinical Practice regulations
• The principles of Good Clinical Practice regulations require the implementation of systems with procedures that bring about complete quality at every stage of the clinical trial
• New Clinical Trials Regulation - EU No. 536/2014 (repealing Directive 2001/20/EC)
• GCP Regulations, Guidance and Additional Resources Who will benefit: This seminar will provide an overview and in-depth snapshot of GCP regulations with a global overview. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the GCP process, including
• Clinical Research Associates who want a greater understanding of the medical device clinical trial process and their role in it
• Clinical Project Managers who are taking on a wider range of responsibilities and need to gain a greater understanding of the regulatory and practical issues involved in medical device clinical trials
• Regulatory Affairs Professionals who may be new to the device industry or new to the clinical trials process
• Clinical Investigators and Clinical Research Coordinators interested in gaining a broader understanding of their role and responsibilities and how these tasks relate to the overall research process
• Regulatory Affairs Management• Regulatory Affairs Specialist • Auditors • Compliance Specialist • Clinical Affairs • Quality Assurance Management • Consultants Agenda: Day 1 Schedule Good Clinical Practices • Introductions and Background • What is GCP? • Why should we have GCP? (ICH GCP/FDA CFR GCP) • The Basic Principles of FDA and ICH GCP • The 13 Basic Principles of ICH GCP • Key ICH Guidelines and FDA Resources • Compliance Guidance Manuals • Impact of ICH GCP in the US • FDA Acceptance of Foreign Studies • FDA GCP Regulation • FDA and International Regulations and Guidance Relating to Good Clinical Practice and Clinical Trials • FDA and Institutional Review Board (IRB)/Independent Ethics Committee (IRB/IEC) • Responsibility of the IRB/IEC • Subject Informed Consent Forms • Informed Consent of Trial Subjects • IRB/IEC interactions with Sponsors and Investigators • FDA's IRB requirements • FDA Responsibilities of Sponsors and Investigators • Investigator Records and Reports and Other Required Documentation for Good Clinical Practices • Disqualification of a Clinical Investigators • ICH Sponsor Responsibilities • FDA-Specific Sponsor Responsibilities • Working with Contract Research Organizations (CROs) • Trial Management • Data Management • Recordkeeping and Documentation • Compensation to Subjects and Investigators and Other Financial Considerations Exercise and Recap of Day 1 • Clinical and Data Management Discussions • Review of Regulatory Documents Day 2 Schedule Good Clinical Practices • Monitor Responsibilities • Complying with the Protocol, Amendments, SOP and Guidance • Fraud and Misconduct • Safety & Adverse Event Reporting • Clinical Trial Protocol and Amendments • Investigator Brochure Requirements • Essential Documents • Tips for Regulatory Inspections - Common Findings • Bioresearch Monitoring Program (BIMO) • BIMO inspection metrics (clinical investigators, IRBs, sponsors, etc.) • Reporting Complaints Related to FDA-Regulated Clinical Trials • GCP Inspections • Additional FDA Guidelines and Resources Exercise and Recap of Day 2 • Clinical and Data Management Discussions • Review of Regulatory Documents Debrief/Adjourn • Recap of topics and key discussion points and take away message • FAQs and latest trends Speaker: David R. Dills Global Regulatory Affairs & Compliance Consultant David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness.
Location: Mumbai, India Date: June 22nd & 23rd, 2017
Time: 9:00 AM to 6:00 PM
Venue: The LaLiT Mumbai Address: Sahar Airport Road, Andheri East, Mumbai - 400059
Price: Register now and save ₹ 2000. (Early Bird) Price: ₹ 14,000 (Seminar for one Delegate) Until May 15, Early Bird Price: 14,000 from May 16 to June 20, Regular Price: 16,000 Registration
Details: NetZealous - GlobalCompliancePanel NetZealous Services India Pvt. Ltd. Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, Bangalore - 560078 Karnataka, INDIA
Phone: 1800 425 9409
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