Clinical Trial Management
- Speaker:Peggy J. Berry
- Product Code:GRC-90322
Live Session - How it works
- Username and Password will be sent to you within 24 hours prior to the webinar.
- Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
- Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
- Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
- Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
- Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our firstname.lastname@example.org
Recorded Session - How it works
- Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
- Please click on the link to access the Recording and type in the password provided in the email.
- Presentation and other handouts will be emailed to you in a pdf format.
Training CD - How it works
- Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.
(For more information about our products contact +1- 248-233-2049)
This training is available for On Site and In Person Seminar
Why You Must Attend:
This program will address the regulatory & legal requirements related to clinical trials and the sponsor responsibilities for effective management of clinical trials. Learn to identification & implement systems to effectively select & manage vendors and clinical sites, and monitoring programs.
GCPs are required to be followed during conduct of clinical trials; it is the responsibility of the sponsor to ensure that all aspects of the study comply with legal and regulatory requirements to ensure integrity and reliability of the data obtained. Requirements include but not are limited to, contract research organizations, clinical investigators, manufacturers of drug substance and drug product used in clinical studies and commercialized, packages, labelers and distributors, testing laboratories and warehouses.
In order to ensure compliance by employees and vendors you must have in a robust program for oversight of their activities, and a program for mitigating against risks that may arise related to key vendors. They must also have internal systems to ensure appropriate oversight and management of the program and data.
This program will provide considerations for vendors,
implementing a robust qualification & selection process, strategies for
oversight and management of vendors, and a risk mitigation approach for key
vendors. It will also provide considerations for internal oversight programs
and tools for various phases of development
Areas Covered During The Session
- Regulatory requirements for clinical trial management
- Legal considerations
- Elements to consider In setting up and managing clinical
- Formats and essential components of SOPs for CTM
- SOP training and implementation
- Systems to assist in CTM
- Vendor selection oversight
This workshop will be beneficial for individuals supporting Clinical Trials, Regulatory Affairs, Compliance Officers, Clinical and Quality Assurance and anyone required to understand Clinical Trial Management
- Clinical investigators, site management and contracting
- Clinical operations
- Project managers
- Data management
- Medical writers
- Compliance officers
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,
She was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA.
In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).