Pre-Conference Workshops: Monday, September 14, 2009

9:00 – 11:30Workshop A: Trusted Strategy to Meet Regulatory Hurdles and Lower Costs and Risk

8:45 Workshop A: Registration

Information Risk Management & Governance

In today's rapidly changing business climate, information governance, risk and control have risen to the top of everyone’s list of concerns. For organizations in the Pharmaceuticals, Biotech and Medical Products industries the cost of not addressing these issues is now too great to ignore and the benefits of fully addressing can be substantial. The dramatic growth in the use of electronic information combined with the need for higher governance standards in business practice requires new technology solutions which are able to address the issues and remove a significant burden from the management team and users at all levels within the organization.

This workshop will go in-depth on pro-active information risk management as well as reactive processes such as Legal Hold and Early Case Assessment. We will explore the frame-work for a breakthrough methodology that is bringing huge operational savings and lowering risks to the Medical Products and Pharmaceuticals industry.

What we will cover:

• Implementing effective information governance approach, real-time policy management to intelligently retain & dispose of data
• Understanding the importance of preparatory approach – surgical archiving
• Managing information in place to reduce risk and cost
• Learning how to proactively and thoroughly dispose of information that is no longer required for operational, regulatory or legal purposes
• Conducting effective Early Case Assessment (ECA) and Legal Hold

How you will benefit:

• Avoiding regulatory and court-ordered sanctions & fines
• Improving efficiency while saving cost
• Selecting the best option for different situations

11:45 – 2:45 Workshop B: Effective Responses to eDiscovery Issues in Pharma - Team, Tools and Technology

11:30 Workshop B: Registration - Lunch will be served

Pharmaceutical, biotech and medical devices companies have unique regulatory requirements and technologies that impact how they conduct internal investigations necessitated by regulatory inquiries, litigation, antitrust and whistleblowers. Pharmaceutical companies will use a variety of resources to conduct the investigation including an internal response team, outside counsel and consultants. The scope of these investigations often goes well beyond simply reviewing email and user created documents but extend to enterprise applications for financial and human resource information, file-shares, document management systems, collaboration tools, and structured databases for sales, marketing, R&D and clinical trials. The manner in which these internal investigations are conducted and the tools used can be an enlightening and thought provoking exercise from which other companies can benefit.

What we will cover:

• Team – learning how to assemble the appropriate response team to conduct and manage internal investigations
• Tools – determining what tools, methodologies and processes are used to conduct and manage internal investigations
• Technology – exploring how technology enhances the internal investigation, and what are the regulators or opposing party’s reaction to these technologies

How you will benefit:

• Understanding the methodologies needed for different types of investigations
• Conducting early case assessment is conducted and used
• How electronically stored evidence is collected, preserved, and reviewed
• Learn how investigations are documented and reported
• Best practices when dealing with regulators and adverse parties and, in particular, relating to their information requests or document demands
• Innovative ways that cost savings are being driven

Workshop Leaders: