Pharmaceutical Outsourcing: A Russell Publishing Publication

January/February 2010

• Managing Risk and Compliance Under the Foreign Corrupt Practices Act

  David H. Laufman White Collar Compliance and Litigation Partner Kelley Drye & Warren LLP

• Ethical Considerations for the Development of Patient Recruitment and Retention Materials

  Joseph Kim Former Manager, Patient Recruitment Specialist Merck & Co., Inc.

• Managing Vendor Relationships

  Sandra Hudgens Project Manager in GCDM Robin Still Manager in GCDM Schering-Plough

• Role of the Data Monitoring Committee and Sponsor in Monitoring Adaptive Designs

  Andreas Sashegyi, Ph.D. Research Advisor, Decision Sciences Group Eli Lilly and Company

• Regulatory Strategy for Starting Material Designation

  Robert H. Seevers, Ph.D., Principal Regulatory Consultant, Global Regulatory Affairs William F. Kluttz, Principal Consultant, Global Regulatory Affairs Eli Lilly & Co., Inc.

• The Integrated Local CMC Service Provider: Toward a Deep Economy of Pharmaceuticals

  Patrick R. Connelly, Sr. Director, Materials Discovery & Characterization Brian P. Quinn, Visiting Scientist Patricia Hurter, VP, Pharmaceutical Development John Condon, Sr. VP, Pharmaceutical Operations Peter Mueller, CSO & Executive VP, Global R&D Vertex Pharmaceuticals

• Plastic Pre-fillable Syringes and Vials: Progress Towards a Wider Acceptance

  Michael N. Eakins, Ph.D. Principal Consultant, Eakins & Associates