Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices Seminar training classes conferences & workshops presented by ComplianceOnline register for training on FindaSeminar.com

Home

Add your seminars

Training Calendar Creator Seminar Venues Training Provider Directory
 

New Seminar Search:  

 

Helpful links

find similar training...
Search by state...
Customer Support


Do you need help finding the right class, date, or location or other assistance?

Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request and receive a prompt reply.

We guarantee this ComplianceOnline training seminar

We are an authorized partner of ComplianceOnline

 

Price protection. The price to attend Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices is set by the training providerThere is no added charge for our services.

We honor most training provider coupons
*.   Call  a representative to see if your discount coupon applies.


Privacy. Your personal information won't be shared with anyone but the training provider ComplianceOnline.


Security. When you register for this seminar on FindaSeminar.com your personal data and payment information is safely collected and processed using secure SSL encryption technology.

Flexibility. FindaSeminar.com offers you three ways to register for Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices seminar by ComplianceOnline.
Register online, by phone (800) 349-1935,or fax (800) 712-5569
Who should attend Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices
Quality managers, Quality professionals, Regulatory professionals, Compliance professionals, Medical device professionals
Reviews
Write and read ComplianceOnline reviews and reviews about the training seminar Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices on the Seminar News Network and the Training News Network.
 

Frequently asked questions and registration options for the training seminar Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

 
Find Training Near You
Use our clickable map to find training near you
Use Our Clickmap
 
hotel seminars meeting space directory
hotel meeting space training facilities restaurant and lodging

 
 
 

request on site training details for the Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices seminarRequest on site training

Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices  

 Email information about this seminar Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices by ComplianceOnline to yourself your manager or associatesEmail this event... View and register for other training seminars like Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices by ComplianceOnline on FindaSeminar.com See similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

For:

Quality managers, Quality professionals, Regulatory professionals, Compliance professionals, Medical device professionals

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

The mission of the Food and Drug Administration is “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.” (see full course description)

 
 
 

 Seminar / Training class dates & locations

 

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search


 

 
 

print the agenda print agenda for the Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices seminar

 

Training Course Syllabus:


Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

The mission of the Food and Drug Administration is “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.”

The Food and Drug Administration’s Center for Drug Evaluation Research, Center for Biologics Evaluation Research and Center for Devices and Radiological Health are responsible for the approval of drug products, biologics and medical devices in their respective industries.

This seminar will outline the structural role of the FDA and a brief introduction to the Food, Drug and Cosmetic Act (the ACT) and how the FDA uses it to enforce the regulatory requirements during the drug, biologics and medical device approval process.

Additionally, this seminar will highlight safety, which is in the FDA’s mission statement, by guiding participants on how to develop a data safety monitoring plan and when it is important to use a Data Safety Monitoring Board. Additionally, various safety management practices will be discussed and the importance of creating a functional adverse event database.

This seminar will also provide the terminology necessary to establish an adverse event monitoring score and the training requirements for study monitors will be discussed in detail. IND and IDE safety reports, IND annual safety updates and Development Safety Update Report (DSUR) will be discussed. Additionally, the best approach on how to discuss safety events with clinical site principal investigators to correct reporting issues. During the life of a clinical trial, several FDA audits are possible, therefore, an organized plan to have in place on how to survive an FDA audit for safety management practices will complete the agenda for this seminar.


Learning Objectives:
Upon completing this course on the "Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices" participants will:

Have a knowledge of the role, structure what the Food and Drug Administration (FDA) regulates
Learn the importance of the Food, Drug and Cosmetic Act (FDCA)
Learn how to setup a data safety monitoring plan and when to use a data safety monitoring board
Learn the various safety management practices employed during clinical studies
Understand the importance of the training requirements of safety monitors (investigators)
Discuss how to create an adverse event database
Learn the submitting process for IND/IDE safety reporting
Understand how to troubleshooting safety events with site principal investigators
Learn how to survive an FDA audit for safety management practices and what Bioresearch Monitoring

Course Outline:
Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Session 1 (90 Minutes): Introduction to the FDA, Food, Drug and Cosmetic Act – Regulations and Guidance

Role, Structure and Operations of the FDA
Good Clinical Practice (GCP) in Clinical Trials
Regulatory Agencies Involved in Clinical Development of Drug Products
Session 2 (90 Minutes): Establishing and Importance of a Clinical Trial Safety Monitoring Plan

Data Safety Monitoring Plan (DSMP) and Data Safety Monitoring Boards (DSMB)
Who Requires What in Clinical Trials
What is the Best Way to Monitor Your Clinical Trial
Primary List of the Required Contents of DSMP
Session 3 (90 Minutes): Outline of Various Safety Management Practices Employed in Clinical Trials

Data Safety Monitoring Boards (What are they and when are they necessary)
Data Monitoring Committees
Institutional Review Boards (IRB) and Ethical Review Committees
Investigator brochure
Safety Assessment Committees
Session 4 (90 Minutes): The Importance and Training Requirements for Safety Monitors for a Successful Clinical Trial

General Information about a Clinical Monitor
Duties in Specific Phases of Clinical Development
Compliance Training on Good Clinical Practice (GCP), FDA Regulations and Guidelines
Knowledge Specific to Site Study (SOPs, Protocols, Investigational Product)
Site Specific Safety Monitoring
Session 5 (90 Minutes): The Process in the Establishment of an Adverse Event Database

Background
Targeted Data Collection – Recommendations
Circumstances in Which Targeted Data Collection Maybe Appropriate
Method for Target or Selection Collection of Safety Data
When Comprehensive Data Collection is Really Needed
Types of Data That Should be Collected


Day Two (8:30 AM – 4:30 PM)

Session 1 (90 Minutes): The Procedures and Requirements for Filing and Updating IND Safety Reports

General Information about Investigational New Drug (IND) and Investigational Device Exemption (IDE)
Mandatory Safety Reporting (IND – Initial and Follow up Reports)
Monitoring the Safety Database and Submitting Safety Reports
Submitting an IND Study
Safety Reporting for Requirements for BA/BE Studies
Review of Safety Information
Session 2 (90 Minutes): Comprehensive Discussion on IDE Safety Reports with Medical Devices

General Information on an Investigational Device Exemption (IDE)
Mandatory Medical Device Reporting
Responsibilities of Investigator-Sponsor Safety Reports in Clinical Trials
Reporting Requirements for Manufacturers
Reporting Requirements for Investigators
MedSun: Shining a Light on Medical Products Safety
Session 3 (90 Minutes): Safety Reporting for IND Annual Safety Update and Development Safety Update Report (DSUR)

General Principles
Relationship of DSUR to the Periodicity Safety Update Report
Durations of DSUR Submissions
Responsibilities for Preparing and Submitting a DSUR
Guidance on Contents of a DSUR
Significant Findings from Clinical Trials During the Reporting Periods
Session 4 (90 Minutes): Troubleshooting Safety Events with Site Principle Investigators to Ensure Study Quality

Background Information – FDA Guidance
Overview of Clinical Investigator Responsibilities
Supervision of the conduct of the Clinical Investigator
Protecting the Rights, Safety and Welfare of Study Subjects
Reporting Timeframes
Types of Reportable Events
Protocol Deviation – Major and Minor ones.
Session 5 (90 Minutes): How to Prepare for an FDA Audit for Safety Management Practices

Discuss legal obligations of FDA audits and Food Drug and Cosmetic Act
Suggestion as to the steps clinical sites take to prepare for the FDA Inspector
Bioresearch Monitoring or BIMO Inspection
What is Form FDA 482?
FDA inspection procedures
Post-inspection procedures and importance of Form FDA 483

Seminar Summary:

The mission of the Food and Drug Administration is “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.” (see full course description)

print this agenda print agenda for the Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices training seminar

 view dates and locations for this seminar

 

 
 
 ComplianceOnline training and seminar course catalog

Click any title to view upcoming ComplianceOnline training event dates and locations, class syllabus and other seminar details

 

     
 

 
     

 

  Also try the advanced seminar search tool

   FindaSeminar HomeComputer Training

unix training
training classes

 © 2002-2018 FindaSeminar.com™ All Rights Reserved.  Terms of Use |  Privacy Policy |  Training News Network