PAREXEL EXPERTS TO SPEAK AT DRUG INFORMATION ASSOCIATION 43rd ANNUAL MEETING, OPENING REMARKS FROM EVENT CHAIRPERSON, DR. ALBERTO GRIGNOLO
BOSTON, MA, June 13, 2007 – Experts from PAREXEL International Corporation (NASDAQ: PRXL), a leading global bio/pharmaceutical services provider, will present key topics at the Drug Information Association’s (DIA) 43rd Annual Meeting in Atlanta, GA, to be held June 17 - 21, 2007 at the Georgia World Congress Center. Dr. Alberto Grignolo, PhD, Corporate Vice President and General Manager of Drug Development Consulting for PAREXEL International and the DIA Annual Meeting Chairperson, will give the meeting’s opening remarks. Attendees will hear PAREXEL experts discuss issues such as risk management, regulatory compliance, patient enrollment, quality assurance, EU regulations and more.
PAREXEL experts will present or chair the following sessions:
Monday, June 18
- Opening Remarks/Plenary Session – Alberto Grignolo, PhD, Corporate Vice President and General Manager, Drug Developing Consulting, PAREXEL Consulting (8:30 – 10:00 a.m. ET)
- Personalized Medicine and Personalized Drug Development: Case Studies and Progress to Date – Part 1 of 2 – Alberto Grignolo, PhD, Corporate Vice President and General Manager, Drug Developing Consulting, PAREXEL Consulting (1:30 – 3:30 p.m. ET, room B407)
Tuesday, June 19
- Risk Management in Clinical Trials – Holger Liebig, Director of Project Management, PAREXEL International (2:00 – 3:30 p.m. ET, room B402)
Wednesday, June 20
- Process Validation During Clinical Development of Biological Medicinal Products – Session Chair: Cecil Nick, MS, Director, PAREXEL Consulting (8:30 – 10:00 a.m. ET, room B304)
- Introduction and Impact of European Directives – Cecil Nick, MS, Director, PAREXEL Consulting (8:30 – 10:00 a.m. ET, room B304)
- Optimizing EU Regulatory Strategy – Session Chair: Cecil Nick, MS, Director, PAREXEL Consulting (10:30 a.m. – 12:00 p.m. ET, room A406)
- My Drug is Approved – Now What? Overview of Required Post-Approval Documents – Julia Cooper, PhD, Senior Director, Worldwide Head of Medical Writing Services (10:30 a.m. – 12:00 p.m. ET, room B405)
- The Advantages of Quality by Design (QbD) Implementation for Emerging Companies – Irach Taraporewala, PhD, Senior Consultant, PAREXEL Consulting (1:30 – 3:00 p.m. ET, room A301)
- Biosimilars in Europe: The EU Regulatory Environment for Biosimilars – Dr. Gerald Haase, FRCPath,Principal Consultant, Drug Development Consulting Practice, PAREXEL Consulting (1:30 – 3:00 p.m. ET, room A402)
- Outsourcing and Late Phase Studies: What to Do, What Not to Do and Why – Session Chair: Ramita Tandon, MA, MPH, Director, Project Management, Peri-Approval Clinical Excellence, PAREXEL International (1:30 – 3:00 p.m. ET, room B401)
- Quality Issues and the Spectrum of Complexity – Cecil Nick, MS, Director, PAREXEL Consulting (3:30 – 5:30 p.m. ET, room B304)
- Compassionate Use of Supply of Unlicensed Products in Europe and Beyond – Susan Sandler, BSc (Hons), MRPharmS, Dip Reg Aff, Principal Consultant, PAREXEL Consulting (3:30 – 5:30 p.m. ET, room A405)
- Role of Ex-Japan Clinical Pharmacology Studies (Ethnobridging) in Expediting Japanese Drug Development – Stanford S. Jhee, PharmD, Director of Research, California Clinical Trials, PAREXEL International (3:30 – 5:30 p.m. ET, room A406)
- Global Clinical Trials and Polyethnic Patient Enrollment: Implications for Regulatory Approval of Marketing Applications – Session Chair: Alberto Grignolo, PhD, Corporate Vice President and General Mgr, Drug Development Consulting Practice, PAREXEL Consulting (3:30 – 5:30 p.m. ET, room B407)
Thursday, June 21
- Gene Therapy Regulations for EU Clinical Trials: Navigating the Maze – Cecil Nick, MS, Director, PAREXEL Consulting (8:30 – 10:00 a.m. ET, room B301)
For the past 25 years, clients have relied on PAREXEL to provide integrated clinical development, regulatory affairs consulting and commercialization services, as well as technologies that expedite time-to-market. Attendees at the DIA Annual Meeting can visit with PAREXEL’s speakers at Booth #724 in the exhibit hall. Demonstrations of PAREXEL’s advanced technologies, including clinical trial management systems, patient recruitment planning technology and drug supply forecasting and visualization software provided by PAREXEL’s subsidiary, Perceptive Informatics, will also be available.
The DIA Annual Meeting is a key industry event, attracting more than 8,000 attendees from 65 countries. The event brings together professionals from bio/pharmaceutical and related industries who are involved in all areas of bio/pharmaceutical development. This year’s meeting boasts nearly 400 sessions, 1,000 speakers and 27 newly added tracks covering current hot topics such as Adaptive Trials/Adaptive Methods, FDA Critical Path Global, Clinical Trials Multi-track and Personalized Medicine.
For more information about PAREXEL visit www.PAREXEL.com or Booth #724 at the DIA’s 43rd Annual Meeting.