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Vendor/Supplier/CRO Compliance – Lessons Learned & Rules to Live By

 
  March 29, 2011  
     
 


ComplianceOnline, Online Event
2011-04-07


This webinar will provide valuable assistance to all regulated companies that utilize third party vendors, service suppliers that provide patient data, diagnostic/lab services or business partners involved in clinical trial or other regulated activities.

 

Why Should You Attend: The pharmaceutical business is increasingly relying on Vendors, Suppliers and Contract Research Organizations (third parties) to perform complex and critical process on their behalf. Third party vendors can streamline the complex process of taking products from laboratory through FDA approval and ultimately to market. Collaboration with third-party vendors create opportunities for reducing costs, increasing R&D productivity and allow the Sponsor Organization to focus on growing other business areas.

Ultimate responsibility for patient safety, quality and integrity of trial data rests solely with the Sponsor. The International Conference on Harmonisation (ICH) states in section 5.2 of its Guideline for Good Clinical Practice that a sponsor is responsible for the ongoing safety evaluation of the investigational products and for reporting any information that could adversely affect the safety of trial subjects. Collaborating with third-party vendors has potential gains and raises new risks. The reach of privacy rules to third party vendors with passage of the HITECH Act (Health Information Technology for Economic and Clinical Health) increases the risk for sponsors and increases the threat of incurring penalties, litigation and threats to a company’s professional reputation.

This course will focus on the Rules to Live By and discuss compliance fundamentals, cost management, impact of the passage of the HITECH Act (Health Information Technology for Economic and Clinical Health), requirements of the HIPAA (Health Insurance Portability and Accountability Act) Security Rule and address mitigating patient safety risks and privacy violations involved in outsourcing R&D. 

 

Areas Covered in the Seminar:

  • The importance of Vendor Compliance Rules and who must comply.
  • The impact of the passage of the HITECH Act, the administrative, physical and technical requirements of the HIPAA Security Rule (45 CFR §160.1031).
  • Strategic Sourcing - the review of supply and demand, development of CRO Selection Criteria, evaluation of suppliers, and the management of select suppliers, requirement definitions and identifying sourcing and contracting requirements in advance of supplier communications.
  • Evaluation and Selection - Goals, priorities and actions plans development with the suppliers and internal teams to ensure that the processes and metrics are in place to achieve each (Milestones and Lessons Learned Project Completion Activities).
  • Fundamentals of Contract Management: Develop and foster relationships with suppliers to ensure clear communication, create an environment of partnership, and agree-to contractually committed levels of service, quality, delivery, and cost.
  • Requesting Proposals & Negotiating Agreements: Preparation, finalization, and distribution of requests for proposal to R&D services suppliers, master services, confidentiality, service standards, and other supplier agreements ensuring high quality, clarity, obtaining competitive costs, document timelines, and mitigating risk.
  • Category Profiling: Documentation basics to create a comprehensive profile for all Services and Suppliers.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that utilize third party vendors that provide products or services to the companies or to the customers or clients of those companies. Management across all industries is tasked with the vendor management and oversight process, and this webinar will assist them in the development of related policies, Request for Proposals, and Contracts.

Personnel from Biotech and Pharmaceuticals who will benefit include:

  • Senior Management who develop procurement policies, compliance rules and vendor selection procedures
  • Auditors who review the 3rd party procurement policies and procedures
  • CROs
  • Independent Consultants
  • Legal, Therapeutic, Study, Clinical Operations, Pharmaceutical R&D, and Corporate Procurement teams
  • Sponsor and study site professionals involved in trial planning and management
  • Administrative study managers, clinical team leaders and CRAs
  • Principal investigators, site managers and study coordinators
  • Regulatory compliance associates
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. 

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Darlene (Dar) Douglas, is a Principal Researcher for Mentor Demographics and a Primary Contributor to the National Institute of Health Cancer Bioinformatic Grid (caBIG). She has a proven track record of successfully achieving timely global regulatory approvals, initiating and effectively managing clinical investigations as well as corrective active programs. She shares unique insights gained from fifteen years experience in clinical trial conduct, validation, quality control, data management systems, post approval market surveillance, supplier management and regulatory compliance in the areas of biopharmaceuticals, medical devices and public utility/power generation industries.
 
Deadline for Abstracts: 2011-04-07
 
Registration:

Attend Live Online Training

$199.00 One Dial-in One Attendee

$749.00 Group–Max. 10 Attendees

(For multiple locations contact Customer Care) 

 

 



E-mail: referral@complianceonline.com
 
   
 
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