Location:
Breakers C, Level 2, South Convention Center
PRESENTER:
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Christopher Topoleski, BA, Director, Federal Regulatory Affairs, American Society of Health-System Pharmacists
Chris Topoleski is ASHPs Director of Federal Regulatory Affairs. In this role, Chris serves as the primary advocate and liaison on regulatory issues to all health-care related federal departments, agencies, and other key stakeholders. He positions ASHP as a credible, valued participant on medication use and pharmacy practice issues under consideration by relevant agencies, such as the FDA and CMS, and establishes and maintains liaison among pharmacy, health, and consumer/patient groups to identify regulatory issues of mutual interest and potential coordination.
Chris has over 17 years experience in the biopharmaceutical industry, including Amgen, Incorporated as a Director in their Government Affairs Office, a Budget Analyst at the Congressional Budget Office (CBO) and has done both health policy and economic consulting.
PROGRAM CHAIR:
JoAnn Harris
Description
This session will provide an update from ASHP, federal officials, and other experts on emerging developments related to preventing contaminated drug products from entering the drug supply chain.
LEARNER OUTCOMES:
Describe the activities that ASHP has initiated in response to the recent compounding tragedy to meet member needs.
Discuss potential follow-up actions from state boards of pharmacy.
Discuss the role of the FDA in pharmacy compounding and manufacturing.
Discuss ways ASHP has taken the lead to ensure the quality of the sterile compounded products.
Distinguish the difference between pharmacy compounding and manufacturing.