Windhover Information proudly presents:

PhRMA Code Revisions

The Implications of the Revised PhRMA Code on Industry Policies
and Processes: Implementing the Changes



Tuesday, Oct. 7, 2008 • 12 PM ET / 9 AM PT • 90 minutes

About the event • Key topics • Speakers • Who should attend • Benefits • Register

Featuring

Greg Levine
Partner / Ropes & Gray

Howard L. Dorfman
Counsel / Ropes & Gray

Ann E. Lewis
Counsel / Ropes & Gray

***EARLY BIRD PRICE available through Sept. 30***
Live webinar: $299 (regular $399)
Live webinar plus complete audio recording: $399 (regular $499)
Audio recording only: $399 (regular $499)

FREE to clients of Ropes & Gray!

REGISTER NOW!

The new PhRMA Code on Interactions with Healthcare Professionals, which at first may appear to be a relatively modest revision of the current Code, nonetheless presents substantial implications for current pharmaceutical company practices. Our three presenters will provide participants with an opportunity to discuss specific issues with respect to those corporate policies and procedures that are most likely to be impacted by the new Code. They will also explore how the new Code will affect a pharmaceutical company as a global organization, well beyond its obvious affect on a company's sales and marketing functions.

The webinar will also consider the impact of the Code on compliance with state laws that regulate marketing conduct and those that require specific disclosures.

The discussion is backed by proprietary Windhover data, delivered in a convenient audio conference format, and capped off with an interactive Q&A round.

So join us, in the convenience of your own office, for a thought-provoking analysis by Windhover's expert editorial team and the government enforcement team from Ropes & Gray. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required.

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Key discussion highlights include:

  • Which internal policies and procedures should a company be reviewing?
  • How do companies resolve the inevitable questions, including:
    • What is a resort?
    • What are the parameters of the out-of-office meal ban?
    • Now that pens are out, what kind of gifts are permissible under the revised Code? What criteria should companies use to determine if a gift meets the new Code standards?
    • How does a company establish a speaker cap, and what is covered by such a payment cap?
  • Beyond sales and marketing: implications for the rest of the organization
  • Use of prescribing data: Will Code implementation require a new process?
  • Disclosure of conflicts: What does the Code require and will the bar be raised?
  • The future of the Code: use of the Code by the states and the enforcers, how industry critics view the Code, and the Code's impact on compliance investigations

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Greg Levine
Partner / Ropes & Gray

Greg Levine is a nationally-recognized expert on FDA regulation of pharmaceuticals, biotechnology, medical devices, and cosmetics. He also counsels pharmaceutical and medical device clients on compliance with health care fraud and abuse laws.Mr. Levine's recent work includes counseling relating to the pre-approval promotion of biological products, 510(k) clearance for medical devices, FDA regulation of software, educational grant policies, clinical trials (Good Clinical Practices), clinical investigator disqualification, Good Manufacturing Practices, orphan drug exclusivity, pharmacy compounding, and product recalls across a range of FDA-regulated products.

Mr. Levine is resident in the firm's Washington DC office and is a graduate of Georgetown University Law Center (1996) and Brown University (1990).

 

Howard L. Dorfman
Counsel / Ropes & Gray

Howard L. Dorfman has over 30 years of experience in managing legal issues critical to the pharmaceutical, biotech and medical device industries, including FDA regulatory practice, compliance management, fraud and abuse and product liability. Immediately before joining Ropes & Gray’s Life Sciences Practice Group, Mr. Dorfman served as chief legal officer of the pharmaceutical division of Bayer Healthcare LLC, where he was responsible for legal oversight relating to the commercial, regulatory and compliance activities of the company's U.S. pharmaceutical operations. Mr. Dorfman also worked at Bristol-Myers Squibb for 23 years as counsel for litigation, where he oversaw and directed nationwide mass tort litigation involving hormones, antibiotic (tetracyline), and medical device (silicone implant) product, and later as counsel to the U.S. Medicines Group, where he was responsible for the legal functions relating to the cardiovascular franchise.

His major areas of expertise include FDA regulatory law; fraud and abuse; compliance programs; risk management processes; mergers and acquisitions; corporate governance; and licensing. Mr. Dorfman is resident in the firm's New York office and is a graduate of Brooklyn Law School (1975) and Yeshiva University (1971).

 

Ann E. Lewis
Counsel / Ropes & Gray

Ann E. Lewis was an early and forceful advocate for the need to understand and communicate the government's compliance expectations to the pharmaceutical industry. During her tenure in the pharmaceutical industry, which began in 1980, Ms. Lewis has been responsible for creating and implementing health care law compliance programs at Pfizer and Bristol-Myers Squibb. As a member of Ropes & Gray's health care practice in New York, Ms. Lewis counsels on the development and communication of health care law compliance policies, as well as other elements of compliance programs, including creative approaches to training, auditing, monitoring and investigations.

Ms. Lewis served as a prosecutor in the office of the New York County District Attorney and as an Assistant Counsel to the Governor of the State of New York. She is a graduate of Wellesley College (1970) and Columbia Law School (1973).

This webinar will be useful for anyone involved with pharmaceutical sales and marketing or industry interactions with healthcare professionals:

  • General counsel and other corporate counsel with responsibility for US product promotion or health care law compliance
  • Compliance officers and managers with US responsibility
  • Sales and marketing managers or team leaders
  • Medical affairs managers or executives

What does registration get me?
  • One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
  • One (1) password to a website on which you'll be taken through the presenter's slides as they speak to them.
  • An interactive Q&A round with speakers: Type your questions on the website during the presentation, for the speakers to address afterward.
  • Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
  • The insight you've come to expect and respect from Windhover and our guest speakers.
What are the unique benefits of a webinar?
  • Lower cost and, therefore, higher value. Your entire team can listen in one room.
  • No travel required. You just have to walk to your conference room.
  • A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
  • Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
  • Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time!
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  • Register online: Click here for the live webinar
  • Register online: Click here for the live webinar PLUS recording
  • Buy the recording online: Click here for just the recorded webinar
  • Register by phone: 1 (908) 547-2159
    Ropes & Gray clients must register by email or phone
    to get this webinar FREE.
  • Bill me: To be invoiced simply complete and submit this form:

Registration Form

The Implications of the Revised PhRMA Code on Industry Policies
and Processes: Implementing the Changes
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