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Sdran program announcement

Crisis Management
Crisis Management
Thursday, July 26, 2007
Favrille (directions at end of this message) 10445 Pacific Center Court, Conference Room M
Joyce Williams, MBA, RAC Del Stagg, PhD Brian Donato, JD
Laura Guy, MS, RAC
Regulatory Liaisons, Principal
Regulatory and Quality Consultant

Program Summary
This program will cover managing crises related to:
1. When the government alleges there has been misconduct in the approval process 2. When a company confronts catastrophic failure in late-stage clinical trials Problems that arise in the late stages of the product approval process can be very difficult for a company to recover from. This presentation will discuss ways to effectively deal with the government and other involved audiences, as well as how to handle the impact of this type of crisis on the company’s reputation, its management and on individual employees. The process of preparing for and managing crises is described, followed by interactive discussions of some case examples.
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Biographies – Speakers
Joyce Williams
Joyce Williams, RAC is President, ProFocus Regulatory Solutions which provides regulatory and development consulting services to pharmaceutical, biotech, and device companies. Ms. Williams has held management positions in large and small pharmaceutical companies, has experience with investigational and marketed products, and has taken products to regulatory approval. She was Vice President, Regulatory Affairs at Arena Pharmaceuticals, Inc., San Diego, California and Vice President, Regulatory and Clinical Affairs at Telios Pharmaceuticals, where she was responsible for regulatory, clinical, and quality assurance for the company’s drug and device products. Ms. Williams holds a BA in chemistry from Case Western Reserve University and an MBA from Pepperdine University and teaches in the Regulatory Affairs masters program at San Diego State University. She is a past Chair of RAPS and past Chair of the Certification Board. Del Stagg, PhD
Dr. Stagg joined Artes Medical with over 25 years of experience in medical products having successfully licensed medical devices, pharmaceutical and biologic products with the FDA and other regulatory agencies around the world. Dr. Stagg obtained doctoral degrees in physiology and pharmacology from Duke University. Del began his career developing medical devices for Becton Dickinson, at a Fortune 500 medical device company, holding various positions from Senior Scientist to Director, Safety Evaluations. Del transitioned from medical devices to pharmaceutical and biological products via working with a Contract Research Organization for three years where he was responsible for clinical studies, product development strategies and as manager of regulatory affairs. Del moved to California in 1993 to join the Regulatory Affairs Department at Allergan. At Allergan, Del was responsible for leading the project team and regulatory team that licensed Alphagan®. Del next took regulatory leadership for BOTOX® and was responsible for the expansion of the license to include the indications of Cervical Dystonia, and Hyperhidrosis. Del was also responsible for the registration of BOTOX® Cosmetic. Brian Donato, JD
Brian Donato is a Partner in his firm which has headquarters in Washington, D. C. and assists clients with questions regarding the regulation of foods, drugs, medical devices, cosmetics and biologics products. Mr. Donato manages his law firm’s Irvine, California offices. A 1970 graduate of the University of Virginia School of Law, Mr. Donato is admitted to practice in California, Florida, Virginia and the District of Columbia. He is the recipient of an FDA Commissioner’s Special Citation for his work in helping FDA communicate with members of the regulated industries. He is also the recipient of awards from FDLI, RAPs and The Orange County Regulatory Affairs Discussion Group. In January of 2001, he received The William J. Brennan, Jr. Award from The University of Virginia School of Law for his efforts in teaching trial tactics and techniques at the law school. Recently, Mr. Donato represented his law firm as a speaker at an international generic drugs conference in Shanghai, China and in making presentations in Jakarta to representatives of the government of Indonesia on a variety of topics related to medical products regulation in the United States. Mr. Donato has authored a number of papers and articles on regulatory law issues and on the subject of litigation, specifically including product liability litigation. He lectures to postgraduate students at the University of Southern California School of Pharmacy on various regulatory topics related to the manufacturing, marketing, sale and importation of medical products. He frequently addresses audiences and presents papers at conferences, seminars, workshops and other programs involving issues related to the Federal Food Drug and Cosmetic Act and FDA’s regulations as well as the similar laws and regulations of the State of California. ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
Registration Form
Yes, I will be attending the SDRAN program on:
Crisis Management
Thursday, July 26, 2007, at Favrille beginning at 5:30 pm Company:
e-mail (required):
My mailing address/contact information has changed.
------------------------All payments should be made by cash or check only-------------------

Preregistration (postmarked by 19 July 2007):

On-site registration (Day of meeting or postmarked after deadline):

2007 SDRAN membership:
$40.00 (you can pay the lower meeting rate) - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - SEND YOUR REGISTRATION FORM AND PAYMENT TO:

Jody Surowiec, SDRAN
P.O. Box 927595
San Diego, CA 92192-7595
Please make your reservation early.
Print Registration Form
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Preregistration Policy*:
Persons are considered “preregistered” and may pay the preregistration fee if their registration form and check are postmarked one week (7 calendar days) before the meeting. All other registrants must pay the onsite registration fee. Refund/Cancellation Policy:
o Can send substitute/replacement (advance notice requested) o Full reimbursement ONLY if notified 1 week in advance o No refund if cancellation is not made more than 1 week in advance o Can send substitute/replacement (advance notice requested) For refunds/substitutions, please notify Mary Wilhelm, VP Membership at *Note about the new preregistration policy:
Because SDRAN values its members and their feedback, we are implementing some changes to improve the quality of our programs. In order to provide enough handouts of the presentations, adequate seating, and sufficient refreshments, SDRAN is more clearly defining its preregistration policy. Individuals who preregister may attend the monthly meeting for $5 less than those who are unable to register in advance. It is the continued goal of SDRAN to provide its members with high-quality educational programs while keeping fees to a minimum. ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
Directions to Favrille:
From North County
Take Interstate 5 South to 805 South Exit Mira Mesa Blvd./Sorrento Valley Rd. Turn left onto Sorrento Valley Rd./Mira Mesa Blvd. Travel east approximately 1 mile, then turn left on Pacific Heights Blvd. Turn right on Pacific Mesa Blvd. Turn right on Pacific Center Blvd. Turn left onto Pacific Center Court Favrille is located on the right. The meeting will be held in 10445 Pacific Center Court From South Bay
Take Interstate 5 North Exit Sorrento Valley Rd. Turn left at stop sign, then take an immediate right across railroad tracks Turn right at second light onto Vista Sorrento Parkway Turn left on Lusk Blvd. Turn left on Pacific Center Blvd. Turn left onto Pacific Center Court Favrille is located on the right. The meeting will be held in 10445 Pacific Center Court From East County
Take 52 West to 805 North Exit Mira Mesa Blvd./Sorrento Valley Rd. Turn right onto Sorrento Valley Rd./Mira Mesa Blvd. Travel east approximately 1 mile, then turn left on Pacific Heights Blvd. Turn right on Pacific Mesa Blvd. Turn right on Pacific Center Blvd. Turn left onto Pacific Center Court Favrille is located on the right. The meeting will be held in 10445 Pacific Center Court


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