Location:

Presenter:

Topic:

Quebec, Canada

Jacqueline Montalibet, Bionalytical Scientific Advisor, Anapharm

“Pharmacokinetic Characterization of Mycophenolate Mofetil and its Metabolite, Mycophenolic Acid in Normal Healthy Volunteers”

Location:

Chair:

Topic:

Cambridge, MA

William M. Egan, PhD, Vice President, PharmaNet Consulting

" Vaccine Adjuvants”

Location:

Co-Moderator:

Title:

Copenhagen, Denmark

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance

“The Spectrum of Anti-Infectives”

Location:

Co-Chair:

Title:

Speaker:

Topic:

Amsterdam, The Netherlands

Philippa Smit-Marshall, MD, Vice President, Medical Affairs

Modern Clinical Development Outsourcing Strategies

Jeffrey P. McMullen, President & CEO

“Models for Outsourcing in Clinical Research”

Location:

Speaker:

Topic:

Boston, MA

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

"Regulatory Challenges for Biologic/Drug Combination Products”

Location:

Instructor:

Topic:

Philadelphia, PA

William Egan, PhD, Vice President, PharmaNet Consulting

“Stability and Specifications for Biological and Biotechnology Derived Products”

Location:

Speaker:

Topic:

Speaker:

Topic:

Dallas, TX

Zia Haque, Associate Director, Data Management

“Project Management in Clinical Data Management – What is the Need?”

Bernadette Brown, Manager, Data Management

“When Coding Counts: Creating a Conscious Coding Environment”

Location:

Speaker:

Topic:

Philadelphia, PA

Peggy Schrammel, Vice President, Clinical Research (Phase IV Development)

“Strategies for Effective Sponsor/CRO Collaborations for Post Approval Studies – Creating a Long Term Partnership”

Location:

Chair:

Topic:

Wilmington, DE

William Egan, PhD, Vice President, PharmaNet Consulting

“Regulatory Issues Specific to New Substrates”

Location:

Speaker:

Topic:

Speaker:

Topic:

Speaker:

Topic:

Frankfurt, Germany

Jeff Freitag, MD, FSCP, Senior Vice President, PharmaNet Consulting

“Clinical Trial Issues in Biosimilars”

Fethi Trabelsi, Director, Scientific and Regulatory Affairs, Anapharm

“Clinical PK/PD Requirements for Biosimilars”

Alexi Assmus, PhD, Immunochemistry, Taylor Technology

“Bringing Biosimilars to Market in Europe, Canada and the US: A Comparison”

Location:

Chair:

Topic:

Speaker:

Topic:

Buenos Aires, Argentina

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance

“Pharmacovigilance in Hospitals”

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance
Topic: “Pharmacovigilance from an Industry Perspective”

Location:

Speaker:

Topic:

Houston, TX

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

“Potency Assays: What are the Requirements and Why”

Location:

Speaker:

Topic:

Princeton, NJ

Pierre Olivier Tremblay, M.Sc, Senior Pharmacokineticist, Anapharm

“Modeling and Simulations in Product Development”

Location:

Chair:

Topic:

Geneva, Switzerland

William M. Egan, PhD, Vice President, PharmaNet Consulting

“Stability Evaluation of Vaccine Throughout the Product Life Cycle”

Location:

Speaker:

Topic:

Melbourne, Australia

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

“Biologic/Device Combination Products – A Regulatory Perspective”

Location:

Speaker:

Topic:

Barcelona, Spain

Kris Davé, Director, Clinical Trials Supply Management

“Regulatory and Risk Management in Drug Device Development”

Location:

Speaker:

Title:

San Diego, CA

Gary Fishbein, MD, MPH, Senior Medical Director

“Proving Clinical Effectiveness in Oncology – How are Alternatives to Mainstream Pathways and Endpoints Evolving and With What Impact on Clinical Trial Design and Approval”

Location:

Speaker:

Topic:

Panelist:

Topic:

Singapore

Christophe Tournerie, MD, Vice-President, Clinical Research

“Rising Cost of Clinical Trials in Asia”

Christophe Tournerie, MD, Vice-President, Clinical Research

“Effective Planning and Negotiating your Budgets with Partners”

Location:

Speaker:

Topic:

Mumbai, India

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance

“Outsourcing in Pharmacovigilance – CRO Perspective”

Location:

Chair:

Topic:

Speaker:

Topic:

Berlin, Germany

Andrew Fleming, Executive Director, Business Development

“Strategic Expansion into Emerging Economies – Tapping into cost-Effective Resources Together”

Philippa Smit-Marshall, Vice President, Medical Affairs

“Paediatric Investigation Plans – Challenges for the Outsourcing Department”

Location:

Speaker:

Topic:

Reston, VA

Andrew C. Chang, PhD, Executive Director, PharmaNet Consulting

"Efforts to Improve Methodologies/Analytics for Plasma-Derived Products during the Characterization of Approved Products"

Location:

Chair:

Topic:

Roundtable Facilitator:

Topic:

Chair:

Co-Presenter:

Topic:

Arlington, VA

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance

“Methodologies/Technologies to Improve Safety”

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance

“Marketing and Drug Safety: Enemies or Allies”

Peggy Schrammel, Vice President, Clinical Research, Phase IV Development

Lori Budman, Manager, Clinical Research

“Endpoint Trials as a Risk Management Tool”

Location:

Speaker:

Topic 1:

Topic 2:

Poster
Presenters:

Topic:

Atlanta, GA

Saleh Hussain, Director, Bioanalytical Operations, Anapharm

“Dealing with Contamination and Carry-Over in Analytical Research”

“Root Cause Analysis During Out of Specification Investigation: A Step-By-Step Procedure”

Samuel Gu, RI Research Scientist;

Nuno Santos, Bioanalytical Investigator;

Aimin Tan, RI Coordinator;

Sharmila Van Heer, RI Coordinator; and

Saleh Hussain, Director, Bioanalytical Operations -- Anapharm

"Evaporation-Free and Automated Method for Determination of Diacerein (Rhein) in Human EDTA Plasma by LC-MS/MS"

Location:

Speaker:

Topic:

Bethesda, MD

Robert Dodge, PhD, Laboratory Director, Immunochemistry, PharmaNet

"Assays to Monitor Immunogenicity"

Location:

Chair:

Topic:

Washington, DC

William M. Egan, PhD, Vice President, PharmaNet Consulting

“Biogeneric Drugs”

Location:

Speaker:

Topic 1:

Topic 2:

Vienna, Austria

William M. Egan, PhD, Vice President, PharmaNet Consulting

“Stability Testing for Biologics: A Lifecycle Approach”

“WHO Guidance for Stability Testing of Vaccines”