ISPE’s 2006 Annual Meeting will kick off 5-8 November in Orlando, Florida, USA, at the Walt Disney World Dolphin.

We hope you can join us and participate in more than 30 informative and balanced programs including classroom seminars, interactive workshops, discussion forums, and a keynote session featuring Moheb Nasr, Director, ONDQA, CDER, of the FDA. He will present the FDA perspective on the need for strategic innovation in the industry. In addition, Nat Ricciardi, President of Pfizer Global Manufacturing, will also offer insights and the necessities of innovations in our changing industry.
Educational programs have been developed to provide delegates an opportunity to explore major trends occurring in our global industry, and in keeping with ISPE tradition, all educational programs will be taught by leading industry experts from around the world.
Highlights of this amazing conference include:

INSIGHT INTO AND PREPAREDNESS FOR DRUG SHORTAGES
The Drug Shortages and Industry Preparedness session will address high level issues in the search for effective solutions to unusual circumstances of changing world conditions, pandemic flu, biological terrorist threats, and industry changes. Dr. Bruce Gellin, Director of the National Vaccine Program Office, HHS, will lead the day-long session, which will include the FDA and other leaders.

REGULATORY REPRESENTATIVES
Representatives from regulatory agencies will take part in sessions, including Moheb Nasr, Director, ONDQA, CDER, of the US Food and Drug Administration, who will present the keynote address and give the FDA’s perspective on the need for strategic innovation in the industry.

ICH Q9
Risk Management for Highly Hazardous Compound Manufacturing is a first-time, one-of-a-kind session with representatives from the FDA and EMEA on hand to discuss the new baseline MAPP guide and highly-hazardous compounds. This session will build on the presentation given to the FDA on 25 January 2005 to address using a risk-management approach based on the International Conference on Harmonisation (ICH) Q9 document to assist in the decisions for employing risk control strategies, specifically when dealing with highly hazardous compounds.

VISION INTO ASTM
Companies who adopt the proposed ASTM Standard governing risk-based qualifications stand to gain significant advantages in the cost and time required to deliver manufacturing facilities. ISPE will hold two sessions to bring attendees the latest information on ASTM, including a one-day workshop to give an in-depth session of how to apply the principals of this Standard to give companies a distinct competitive advantage: ASTM: A Vision for the Future: Practical Applications of the Proposed ASTM Standard for a Science and Risk-based Approach to Qualification; and an additional briefing: ASTM Standards for PAT and General Pharmaceutical Manufacturing: A Status Report.

QUALITY BY DESIGN
Quality by Design will be discussed in sessions and series, including Process Development in the New Quality By Design Framework; and the Regulatory Series: Quality By Design - What the ICH Guideline Q8 Says About QBD6. These sessions are “must attends,” delivering important information on this critical topic.

RFID TRENDS AND SOLUTIONS
RFID Trends, Challenges and Solutions for Life Sciences session at ISPE’s Annual Meeting provides a uniquely balanced focus on business process improvement, organizational change and key technology concepts that prepares the attendee to quickly progress from learning to seeing to doing. The RFID Technical Institute, in collaboration with the International RFID Business Association, has assembled this concentrated thought-provoking session.

CPIP™  - A NEW GLOBAL INDUSTRY PROFESSIONAL CREDENTIAL
Professionals can be the first to find out about the industry’s new credential by attending a workshop on the new Certified Pharmaceutical Industry Professional (CPIP™) credential. Details will be made available through the ISPE Professional Certification Commission at free workshops that feature CPIP description, eligibility criteria, application process and examination overview.

JOURNAL OF PHARMACEUTICAL INNOVATION
Meet the editor and committee members of the newest, most innovative journal in the industry – ISPE’s new Journal of Pharmaceutical Innovation.  JPI answers the challenge from the FDA when they asked ISPE to play a prominent role in their plan to “enable fully flexible manufacturing concepts, within regulation, using the best engineering and scientific principles available, improving business and taking risk into consideration.” This leading-edge publication will be the first global journal to focus exclusively on articles on innovation in pharmaceutical research, manufacturing, quality management, science and risk-based approaches, quality by design, and cGMPs for the 21st century.

FOYA AWARDS: THE BEST OF THE FACILITIES
Join ISPE, INTERPHEX and Pharmaceutical Processing magazine to hear about the cutting-edge design of FOYA winner Baxter BioPharma Solutions, which was named the winner of the 2006 Facility of the Year Award for its Phase IV Vial and Syringe Filling Project in Bloomington, Indiana, USA. Previous winners will also be on hand to discuss their winning entries.

NIPTE: EDUCATING OUR FUTURE
The National Institute for Pharmaceutical Technology and Education (NIPTE) Colloquium, will feature speakers Jon Tomson, ISPE Technical Advisor, and Prabir Basu, Executive Director of NIPTE, who will lead a lively discussion between the academic community and senior leadership from the industry and regulatory authorities regarding university activities, to develop new professionals with the manufacturing science skills that will be needed in the years to come. 

INDUSTRY LEADERS
Nat Ricciardi, President of Pfizer Global Manufacturing, will offer his insights and the necessities of innovations in our changing industry, during the keynote session.  AstraZeneca will present its critical learning experience of the FDA’s CMC pilot program and how they are applying science-based and risk-based approaches to the development of a new product.

For more information about other sessions and highlights, or to register, go to 
www.ispe.org/annualmeeting or call ISPE at +1-813-960-2105.
Sponsorship and exhibit opportunities are still available for the 2006 Annual Meeting. Please contact Dave Hall, ISPE Director of Sales, by tel: +1-813-960-2105, or e-mail: dhall@ispe.org

Share This

In an effort to focus on innovation, ISPE will promote our 2006 Annual Meeting through its latest communication vehicle, the ISPE Annual Meeting blog. This Web log – or blog, for short — is similar to an on-line diary or journal, with the most recent entries at the top.

The Society will post details on the Annual Meeting, and Members can send in questions or comments and related information.

The blog will include summaries of important sessions, keynote speakers, photos of Members and other information, and will be linked to the ISPE Web site for additional information. Members will be able to post comments on the blog from their computers and at an onsite kiosk with laptop computers.

Read this daily to find out information from session leaders, information on Community of Practices, and industry news.

Interact with other ISPE Members by posting your thoughts, observations, etc., at the blog. Share your best part of the day, information you brought away from session leaders, and even fun things you did with your family.

So have fun and blog away!

Share This