Sunday, September 21
Participation in the Sunday Executive Workshops is open to all AdvaMed 2008 registrants. Please RSVP participation in the Executive Workshops by writing to program@advamed2008.com (indicate name, company, and which workshop).|
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2:00-6:00 p.m. |
Sunday Executive Workshops |
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2:00-6:00 p.m. |
Executive Workshops |
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Panel: |
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2:00-6:00 p.m. |
Executive Workshops |
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Panel: |
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2:00-6:00 p.m. |
Executive Workshops |
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Quality through the Product Value Chain: From Engineering to Product Recalls. Learn from real-life experiences!
Sunday, September 21, 2:00-6:00 p.m.
Room Location: Hoover
Workshop leader: Nikki Willett, Pilgrim Software
Changes in regulations, complexity of products, globalization, and economy all have impact on today’s medical device manufacturer costs, product quality and overall business operations. Join AdvaMed and Pilgrim Software in this free pre-conference workshop to learn about the hottest topics and challenges in engineering, manufacturing, and quality and benefit from the lessons learned and best practices from key industry experts that have increased their operational excellence and quality throughout the product lifecycle. The pre-conference workshop is held in three (3) sessions:
Session One: Going Global - addressing design control in an economic environment where R&D and manufacturing operations span the globe
Globalization demands new methods to efficiently address design control for R&D and manufacturing operations. Perhaps your company has grown globally by acquisition; additionally, you may have invested in global expansion by establishing new operational units around the world to leverage lower cost labor and/or specialized knowledge and technology. Whatever the case may be, if you're a global company, you have added complexity in your design control systems that were not present when you operated on a more local basis. In this session, a panel of medical device industry experts including from some companies such as Siemens Medical, Zimmer, St. Jude Medical and others, will characterize their company's overall approach to maintaining and assuring globalized design control, as well as addressing specific global issues, including: communication and collaboration mechanisms, multi-language and literacy concerns, and opportunities for increasing efficiency.
Speakers:
The panel will be hosted by Jim Thompson, Ph.D. – Director Healthcare Industry Solutions from Siemens PLM with case studies from several executives from major medical device organizations. Session Two: Meeting the challenge of the new quality paradigm – From supplier to customer –- Driving quality throughout the entire supply chain
From toys to medical devices to food supplements, from “made in the USA” to “made in China” quality management is at the forefront of every manufacturer driven by global consumers wanting nothing but 100 percent safe products. For medical device companies there is no 99.9% it is either 100% or off the hospital or retail shelf or off the product list. However, managing quality has become more difficult as we expand the number of global suppliers, manufacturing sites and external contractors needed to drive the right product at the right price at the right cost to the right place and at the maximum quality. This panel of key leading industry knowledge experts will provide a view of the key issues and best practices on how to manage quality in your global upstream and downstream supply chain components. From supplier management to manufacturing trace and track to warehouse life cycle control management learn how the pieces fit together to drive the perfect lean quality supply chain.
Speakers:
The panel will be hosted by Phil Friedman, Vice President, Consumer and Life Sciences; and Riya Cao from QAD, with case studies from several executives from major medical device organizations.
Session Three: Pre-Event Strategy for Product Recalls – Avoid the nightmare, reduce risk, and protect people through pre-event planning and strategy for recall execution
It’s clear that all companies – particularly those whose products have the potential of being recalled – should be prepared for the worst. Getting a simple plan in place and taking measures to ensure its effectiveness are necessary in diverting crisis long before an event arises. Despite the fact that regulations and FDA guidance strongly recommend comprehensive recall planning, many companies have major challenges in determining what information is needed for a recall, as well as gathering that information and distributing it to the appropriate people. In the event of a recall, preparation may lend much more than a hand; it may save your company’s reputation. In this session, a panel of industry experts, including Cardinal Health and Stericycle, will discuss the important aspects of pre-event preparation, mock recall and assessments, and recall action team leadership and responsibilities. Learn valuable lessons on how to ensure public safety, be certain that all recall operations are effective and the public is protected.
Speakers:
The panel will be hosted by Ken Edwards, Vice President of Recalls from Stericycle, with case studies from Cardinal Health and other executives from major medical device organizations.
Being Prepared for Government Investigations and Other Lawsuits
Sunday, September 21, 2:00-6:00 p.m.
Room Location: Harding
Part I, 2:00-4:00 p.m.: Anatomy of a Federal Investigation
Workshop Leader: McGuire Woods, LLP
Regardless of whether your company has been the target of a government investigation or inquiry, no company in the medical device industry is immune to the potential of becoming a target. This interactive panel will lead participating companies through different types of investigations and how to best prepare in advance. Participants will engage in a mock case study and learn from our expert panelists how to maneuver around potential pitfalls in the process of responding to any government investigations. Some of the questions answered by this interactive session will include:
- How to prevent regulatory inquiries from becoming criminal issues
- The process of reviewing and production of documents
- Expectations of federal and state agencies
- Trends and strategies of State and Federal prosecutors offices
- The importance of public and private communications during and after an investigation
Part II, 4:00-6:00 p.m.: Dangerous Document: Avoiding Landmines in Your Firm’s FDA Documents and Emails
Workshop Leader: Nancy Singer, Compliance Alliance
Guidant, Bayer, Merck, Eli Lilly and American Home Products were sued. During discovery, they were forced to produce their employees’ emails and documents that they believed were confidential. These documents contained inflammatory statements that embarrassed the companies. They had to enter into expensive settlements. Microsoft was subject to the same fate, as Bill Gates wrote in an email, “How much do we have to pay you to screw Netscape?” If you or your colleagues have not been trained on how to write complete, accurate emails and documents that show the depth of your corporate culture of compliance, your firm could be subject to a similar costly result.
Nancy Singer, former federal prosecutor and defense attorney will lead an interactive workshop. Using examples from firms’ files, the students will be divided into teams and will discover:
- Ways poorly written documents can be a source of humiliation
- How documents tell the story about the corporate culture
- The importance of documenting the firm’s risk management activities
- The danger of leaving blanks and using white-out in required records
- The effect of inappropriate warnings
- The importance of having and following a good document retention program
- Words not to include in documents
- The practices that will draw attention to specific documents if a firm is sued
- The consequences of not monitoring employees’ emails
CFO as Enterprise Risk Management Leader: How Financial Executives Add Value to This Critical Process
Sunday, September 21, 2:00-4:00 p.m.
Room Location: Coolidge
Workshop Leader: Tom Konopka, Medmarc / The Hartford
Enterprise risk management (ERM) has the ability to help medical device companies align people, processes and ideas which support corporate objectives, improve cash flow and earnings, capture opportunities, allocate capital and manage growth. For this process to deliver on its promise it requires board and executive level proactive commitments and a champion to lead the way. Register for and attend this AdvaMed 2008 bonus session and receive actionable ideas for achieving demonstrated compliance with laws and regulations, advancing greater assurance of business continuity and establishing a competitive advantage.
Speakers:
Bruce Belzak, Managing Director and Life Sciences Practice Leader, Marsh
Gary Bucciarelli, Chief Administration Officer, Medrad, a Bayer Company
Timothy Budacki, Principal, Hazard Management Associates
Matt Allen, Senior Vice President and Enterprise Risk Solutions (ERM) Practice Leader, Marsh
Entering the North American Market
Sunday, September 21, 2:00-6:00 p.m.
Room Location: Wilson C
Workshop Leader: Daniel R. Matlis, President, Axendia
Bringing medical devices to the North American market requires a thorough understanding of regulatory requirements, the regulatory process, its participants and the timeframe for getting the job done. Familiarity with these requirements and processes can enhance your business plan and the ultimate success of your marketing efforts in North America.
The workshop will provide a roadmap for the path to successfully bringing medical devices to the North American market, including:
- Start with the end in mind
- Secure your IP
- Build the right team
- Navigating the regulatory approval roadmap
- Don’t wait for perfect!
- Build in Quality Now (QSR)
- You want to get paid?
- If you built it, they still won’t come
Additional components of this workshop include:
- Case Studies and War Stories
- Government Funding Opportunities
- Speakers:
Jo Anne Goodnight, NIH SBIR/STTR Program Coordinator
Don van Dyke, Ontario Ministry of Economic Development & Trade
- Speakers:
- The “Soft Landing”: Finding Partners in the U.S. / Canada
- Speakers:
Jeanne R. O’Connor, Vice President & Chief Development Officer, Select Greater Philadelphia
Jordan Warshafsky, Partner, Ashton Tweed, Ltd.
- Speakers:
- The Reimbursement Landscapes
- Speaker:
Stephen Chan, Executive Director, Boston Healthcare Associates
- Speaker:
- Regulatory Landscapes
- Speakers:
Judy Meritz, Partner, Blank Rome LLP
Carole C. Carey, Director, International Relations and External Affairs Staff, Medical Devices Coordinator for Global HBD (Harmonization By Doing) Programs, U.S FDA Center for Devices and Radiological Health
- Speakers:
This workshop will be followed by an opportunity for one-on-one interaction with the presenters.
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