Clinical Regulatory Pack of 11 Webinars

Agenda

TOPIC 1: Good Clinical Practices Review of ICH E6 (R3) Latest Guidance

Speaker: Charles H. Paul

Duration: 60 Minutes

•    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

TOPIC 2: Trial Master File Requirements and Essential Regulatory Documents

Speaker: Marina Malikova

Duration: 60 Minutes

•    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

TOPIC 3: Selecting and Managing Vendors in Clinical Research

Speaker: Pam Dellea-Giltner

Duration: 90 Minutes

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
TOPIC 4: Risk Management in Clinical Research

Speaker: Marina Malikova

Duration: 60 Minutes

•    Identify and manage risks of clinical trials
•    Perform Cause-Effect Anaylysis 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 5: FDA’s GMP Expectations for Phase I and First-In-Man Clinical Trials

Speaker: Peggy J Berry

Duration: 90 Minutes

•    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

TOPIC 6: GCP Compliance - Audit Preparation and Inspection Readiness

Speaker: Marina Malikova

Duration: 60 Minutes

•    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

TOPIC 7: How to Best Document Clinical Evaluation Report (CER) for CE Mark

Speaker: Dr. David Lim

Duration: 60 Minutes

•    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

TOPIC 8: Clinical Project Management

Speaker: Peggy J Berry

Duration: 90 Minutes

•    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

TOPIC 9: Successful FDA Meeting Preparation and Conduct

Speaker: Peggy J Berry

Duration: 90 Minutes

•    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

TOPIC 10: Medical Device Clinical Investigations to the new EU MDR Requirements

Speaker: Gadi Ginot

Duration: 60 Minutes
 
•    Overview of the new MDR expectations from clinical investigations
•    Intersection with GDPR
•    Intersection with the “clinical evaluation process”

TOPIC 11: EU's New Regulation 535/2014 on Clinical Trials - Insights into Effective Clinical Trials

Speaker: John E. Lincoln

Duration: 60 Minutes

•    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

Course Provider

• 

• John E. Lincoln,
  Principal Consultant ,
  J. E. Lincoln and Associates LLC
  
  

  John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
  
  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.

• 

• Mr Gadi Ginot,
  Founder & CEO ,
  Physio-Logic
  
  

  Gadi Ginot is the current Founder & CEO of Physio-Logic. He previously worked at Advanced Biomedical Research as a VP Clinical Affairs & Business Development. Gadi Ginot attended Tel Aviv University.

• 

• Miss Pam Dellea-Giltner,
  CEO and Principal Auditor ,
  PDG Clinical Consulting LLC
  
  

  Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research Operations. Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management.

  She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager.

  Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.

• 

• Charles H. Paul,
  President ,
  C. H. Paul Consulting, Inc.
  
  

  Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
  
  He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
  
  He has dedicated his entire professional career explaining the benefits of performance-based training

• 

• Peggy J. Berry,
  President & CEO ,
  Synergy Consulting LLC
  
  

  Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

• 

• Dr David Lim,
  President and Principal Consultant ,
  Regulatory Doctor
  
  

  Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

• 

• Dr Marina Malikova,
  Exceutive Director ,
  Boston University School of Medicine
  
  

  Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
  
  Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
  
  In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.