NAPM Workshop to Deal With Scientific, Regulatory Concerns.
The meeting will provide a forum in which NAPM members can meet with representatives of the Food and Drug Administration, the United States Pharmacopeia (USP) and other organizations, says NAPM president Robert Milanese.
"This workshop will bring regulators and the industry together so that the regulatory approval process for generic drug products is both strengthened and streamlined to ensure timely availability of therapeutically equivalent generic drug products," he says.
Activities on October 11 will focus on afternoon committee seminars followed by the evening board of directors meeting.
The morning meeting on October 12 will be highlighted by a session on regulatory and compliance issues.
Participants will include Janet Woodcock, director of the FDA's center for drug evaluation and research, who will discuss challenges facing that unit; Gary Buehler, acting director of the office of generic drugs, who will review issues relating to Abbreviated New Drug Application submissions; and Joseph Phillips, regional director of the mid-Atlantic region of the FDA. Phillips will review field inspection issues.
The October 12 morning meeting will also feature talks by Gordon Johnston, an associate with Lachman Consultant Services, and by John Rapoza, vice president of regulatory affairs for Duramed Pharmaceuticals Inc. Johnston will outline trends concerning the development of generic biologicals; Rapoza will review the industry's concerns over a variety of regulatory and compliance issues.
Regulatory guidances and USP monographs on ANDA submissions and the review process will be discussed Thursday afternoon. The evolution and legal significance of FDA regulatory guidances will be explained by Arthur Tsien, an associate with Olsson, Frank & Weeda, PC (NAPM counsel).
Roger Williams, executive vice president and chief executive officer of the USP, and Eric Sheinin, deputy director of the FDA's office of pharmaceutical sciences, will discuss the use and impact of USP monographs on the FDA review process.
Thursday afternoon will also feature presentations by Joan Janulis, vice president of analytical development and regulatory affairs with Faulding/Purepac Pharmaceutical Co., and Mary Ann Holovac, who represents the FDA's office of information technology's data management services division. Their respective topics will be the impact of FDA regulatory guidances and USP monographs and the patent and exclusivity listing process for the so-called Orange Book.
Bioequivalence study issues will be the focus of the Friday, October 13, session. Speakers for that session and their topics will be:
* Mehul Mehta, director of the FDA's division of pharmaceutical evaluation I, clinical pharmacology, who will discuss the biopharmaceutics classification system.
* C.T. Viswanathan, associate director of the FDA's division of scientific investigations, who will review issues concerning bioavailability and bioequivalence studies.
* Jai Mehta, president of JM Pharma. A sponsor's viewpoint on the monitoring and auditing of bioequivalence studies will be reviewed.
* Dale Conner, director of the division of bioequivalence in the FDA's office of generic drugs, and Murray Ducharme, senior director of pharmacokinetics and pharmacodynamics at Phoenix International Life Sciences Inc. They will examine studies that do not meet the FDA's bioequivalence requirements.