Institute for International Research

What You Will Learn:

• Investment necessary to manufacture anticipated volumes
• Management of API Cost is essential to maintaining a competitive cost structure
• Intellectual property issues • Ensuring Good Manufacturing Practices of API company
• Ensuring appropriate preparation of drug master files for submission to regulatory authorities

About Our Distinguished Workshop Leaders:

Peter Saxon is Principal of the consulting firm, SAXON INTERNATIONAL ASSOCIATES since 1993 specializing in assisting foreign (non-US) companies to meet FDA requirements and guiding them through the inspection and approval process. Prior to that, Peter worked for Ciba- Geigy in various management positions in the Production, Marketing, Regulatory affairs and Business Development areas. He worked for the firm in the US, Switzerland and Egypt.

Ambrose Stafford is Director of API Sourcing at SANDOZ PHARMACEUTICALS, INC. and has over 16 years experience in the API industry. He began his professional career in API manufacturing with Bristol-Myers Squibb in Ireland and progressed through roles of increasing responsibility in manufacturing, strategic planning and sourcing with BMS in Ireland and the US before joining Sandoz in 2001. At Sandoz he has held the positions of Head of Sourcing & Purchasing in the US, Global Head of API Sourcing located in Vienna, Austria before returning to the US to his current position during the integration of Eon, Hexal and Sandoz.

FDA Weighs In on DMFs

"One thing you can help with is the quality of the drug master files, which relate to the active pharmaceutical ingredient. This is often submitted separately by foreign firms who do not have a lot of experience working with the FDA, and are not under direct control of the generic drug makers. These applications are the ones that cause us the most frequent problems, and prompt us to have to start a second cycle of review."

- Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, FDA

PRAISE FOR PREVIOUS WORKSHOP:

"Good overview for API Sourcing people as well as API representatives to understand what we need." -Senior Director, NA Sourcing, TEVA "Very useful! On target discussions and presentations."

- Director of Operations, Haemonetics Corp.

What You Will Learn:

• Tips for communicating with FDA
• The role preparation plays in beating the clock
• Common mistakes made during an ANDA submissiom
• Strategies for eSubmissions

Who Should Attend this Workshop:

• Regulatory Affairs
• Document Control
• Information Services
• Quality Assurance/Quality Compliance
• R&D

About Our Distinguished Workshop Leader:

Candis Edwards, Vice President, Regulatory Affairs, WOCKHARDT USA has over twenty years of experience in Regulatory Affairs, Research & Development, Project Management, Quality Assurance, cGMP Compliance and Quality Control. In her former role as Vice President of Regulatory Affairs at Clay-Park Labs, Inc., a generic topical drug manufacturer located in New York, Ms. Edwards had responsibility for establishing regulatory strategies for submission, approval and post-approval support of all products requiring FDA approval.

PRAISE FOR PREVIOUS WORKSHOPS:

"Candis was excellent and it is clear she knows regulatory!"
- VP Compliance and Regulatory Affairs, PLIVA

"Candis is a very dynamic speaker and knowledgeable and made learning the ANDA process very easy and fun."
- Project Manager, Product Development, SANDOZ

"Candis is very knowledgeable of the content of an ANDA. It was an excellent and informative workshop. It provided a very good overview of over 20 years of regulatory experience with the FDA."
- Director Product Development, MYLAN

What You Will Learn:

Purpose of Paragraph IV certifications and Notice Letters

• Background of Hatch-Waxman
• Orange Book listings
• Types of Certification Letters
• Benefits of First to File
• 30-month stays and 180-day exclusivity period

Effect of Certification and Notice Letters on Litigation

• Use of Certification and Notice Letters at Trial
• Difference between opinion letters and notice letters
• Willful Infringement and Privilege issues
• Pre-Launch Litigation v. Post Launch Litigation

Requirements and Strategies for Paragraph IV certifications and Notice Letters

• Minimum Statutory Requirements
• Timing of Submissions and Notice
• Offering Additional Information to Patent Holder

Recent Developments in the Law

Who Should Attend this Workshop:

• In-House Counsel
• Intellectual Property/PatentLaw
• Regulatory Affairs

About Our Distinguished Workshop Leader:

Richard Basile is a member of the firm St.Onge Steward Johnston & Reens LLC. He has an extensive patent litigation practice with an emphasis on counseling and representing generic drug companies in Hatch-Waxman cases. He has successfully represented generic drug companies at both the trial and appellate levels and has written numerous patent opinions, notice letters and certification letters.