International Leadership Forum

THE INTERNATIONAL LEADERSHIP FORUM (ILF)

is a global advisory group of pharmaceutical manufacturing, development, engineering and quality executives working through ISPE. The ILF is dedicated to providing leadership and direction on critical technical issues facing the industry by:

• Aligning the industry globally
• Establishing dialogue with regulators to discuss critical technical issues
• Identifying opportunities for innovation
• Promoting consistency
• Seeking worldwide harmonization where appropriate

The forum provides direction on focus and priorities to guide the strategic plan and activities of ISPE, and to coordinate interactions with other professional societies.

SENIOR LEADERS IN ACTION

ILF members work in senior management roles with global responsibilities that span:

• Clinical and non-clinical development
• Process development and technology transfer
• Regulatory affairs
• Manufacturing engineering
• Production
• Maintenance and facilities
• Supply chain
• Quality/compliance

UPCOMING MEETINGS

14 June 2013 - Baltimore, Maryland USA
3 November 2013 - Washington DC USA

ILF RESULTS: The GPS

The Global Positioning Strategy (GPS) document is a major Forum initiative resulting from ILF members’ ongoing dialogue around regulatory and technology issues. Envisioned as a technical roadmap to guide ISPE on industry, technical and professional development direction, the GPS document has been in development since 2011. The first draft version of the GPS is now in review by ILF members. The Forum invites comments on the document at GPS@ispe.org.

HISTORY

The ILF was established in April 1990 to enable senior management to discuss issues of common interest among their colleagues worldwide and to meet with senior regulatory agency personnel to discuss ways to improve efficiency and safety. The ILF also provided leadership, direction and resources to initiate the development of baseline guides to establish science-based standards for industry reference and compliance.

To date, all ILF meetings have included participation by senior regulators from the USA, Europe, Japan, Asia, China and beyond. This high-level interaction has led to several important achievements:

• Establishment of baseline guides
• FDA’s revised guidance on 21 CFR Part 11
• ISPE’s invitation to participate as a technical consultant at the July 2003 International Conference on Harmonization (ICH) meeting in Brussels
• ASTM Standard Guide to a Science and Risk-Based Approach to Qualification
• Global Positioning Strategy (GPS) road map document

LEADERSHIP TEAM

• Chair - Lou Schmukler, President Global Manufacturing Supply, Bristol-Myers Squibb
• Past Chairs - Tim Tyson, Chairman and CEO, Aptuit, Inc. (Immediate Past Chair)
  Jim Spavins, Senior Vice President, PTx Pharm Sci, Pfizer, Inc.
• Staff - Nancy Berg, President & CEO, ISPE

For more information on ILF, contact ILF@ispe.org