—Registration Now Open—
WASHINGTON, D.C., May 15, 2007 — The Consumer Healthcare Products Association (CHPA) and the Council for Responsible Nutrition (CRN) today announced the agenda for the one-day Adverse Event Reporting (AER) Seminar to be held Wednesday, June 20, 2007 at the Hyatt Regency in Bethesda, Md.
Through expert speakers and the opportunity to network with industry colleagues, the one-day workshop will provide makers of dietary supplements and over-the-counter medicines with a greater understanding of mandatory adverse event reporting, including submission and maintenance of reports, to comply with the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
The day will begin with the attorney’s perspective as presented by a senior associate from Covington & Burling, Miriam Guggenheim, who will address some of the key areas firms need to focus on under the law. Following Ms. Guggenheim’s presentation, two panelists, including Steve Swantek, president & CEO of PROSAR, will provide practical suggestions as to how companies can appropriately set up an adverse event reporting system. Heidi Horn, associate director, Regulatory Affairs, Perrigo, and co-chair of CRN’s Regulatory Affairs Committee, will discuss some of the unique challenges faced by private label retailers. The final session of the day will include representatives from the Food and Drug Administration (FDA) who have been invited to address FDA’s rulemaking and guidance development process and explain how the Agency plans to handle the incoming and existing adverse event report data. Additionally, the agency has been asked to send a field representative who can specifically discuss the aspects of the auditing process.
Registration is now open online through either the CHPA or CRN websites. Registration for CHPA and CRN members is $195. Nonmember companies are invited to attend the seminar at a rate of $295. The rate for government employees is $100. Continental breakfast and lunch are included in the registration rate. The AER seminar is scheduled to run from approximately 9:30 a.m. to 3:30 p.m., allowing attendees to fly back on the day of the meeting. For those needing hotel rooms, a group rate (subject to availability) is offered at the Hyatt Regency Bethesda until June 6. For more information visit www.chpa-info.org or www.crnusa.org.
Consumer Healthcare Products Association (CHPA), CHPA is the 126-year-old national trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products. CHPA’s web address is www.chpa-info.org.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers. CRN members voluntarily adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices. For more information visit the CRN website http://www.crnusa.org.