On Thursday 16-September-2010 over 125 global attendees, representing some 89 organizations from across pharmaceutical, biotechnology, and generic drug manufacturing industries, along with their suppliers, professional trade associations and regulatory agencies, came together at Merck KGaA in Darmstadt, Germany for the 2010 Open Meeting.  Approximately half of those in attendance were from organizations that are considering joining the 52 ogranizations that already make-up the Rx-360 consortium.

Attendees came to the open meeting to hear from regulators and learn about the consortium’s progress and future plans. As a result of the news announced at the meeting, that the United States Federal Trade Commission has issued a positive advisory opinion letter to Rx-360, progress for the consortium now includes completing two pilot programs.  The two pilot programs that will begin immediately are: Shared Audits (where member suppliers make completed audit reports of their companies available to Rx-360 members), and Third-party Joint Audits (where member companies jointly audit a supplier via Rx-360 commissioned third-party auditors).

A complete list of presentations from the Open Meeting is included below. Presentations are available for viewing or downloading using the following links:

01: Rx-360 Year End Review
02: Rx-360 Legal Considerations
03: High-Level Review of Rx-360 Initiatives
04: EMEA - David Cockburn - EU expectations and current developments
05: EDQM’s Contributions in Securing the Supply Chain - Susanne Keitel
06: FDA - Janice Soreth - Supplier Management - Risk Based Approach

The following presentations were made throughout the day:

Elmar Schnee, Member of the Executive Board and General Partner of Merck KGaA, Rx-360 member company Merck KGaA, welcomed attendees to the Merck site and opened the meeting.

Mary Devlin Capizzi and Joanne Lewers, Rx-360 secretariat Drinker, Biddle & Reath LLP, discussed the breaking news of the advisory opinion received the same day from the US Federal Trade Commission (see Sept 16 press release.)

David Cockburn, Head of Manufacturing and Quality Compliance, European Medicines Agency (EMA), discussed EU expectations for starting materials and current developments within the agency.

Dr. Susanne Keitel, Director, European Directorate for the Quality of Medicines & Healthcare (EDMQ), provided EDMQ’s perspective and lessons learned on globalization and the challenges of securing the supply chain.

Dr. Janice Soreth, Deputy Director (Medical Products) Europe, Office of International Programs, U.S. Food and Drug Administration (FDA), provided a talk on FDA’s collaboration with international partners and shared lessons learned for Rx-360 initiatives.

Eric Berg, Rx-360 member company Amgen, provided a year in review summary and highlighted the work of the consortium in four areas: sharing information, endorsing and creating standards, developing the shared audit programs, and embracing and adopting technologies.

Brian Johnson, Rx-360 member company Pfizer, reported that 12 member supplier companies have agreed to provide over 160 audits for use in the shared audit program pilot now that the FTC opinion has been issued.  The pilot will begin immediately.

Janice Berger, Rx-360 member company AstraZeneca, and Jack Brinnier, Rx-360 member company Watson, provided an update on third-party joint audit program.  In the pilot to begin immediately, 20 API companies and 20 excipient companies will be audited by Rx-360 commissioned third-party auditors.  Results of the pilot are expected to be available at the beginning of Q2, 2011.

Rauol Biskupek, Rx-360 member company VWR, provided an update on the standards that Rx-360 has endorsed and created thus far.

Representatives of pharmaceutical manufacturers, suppliers and regulatory agencies discuss topics such as quality and drug safety throughout the pharmaceutical supply chain as well as specific regulatory aspects with attendees (from left): Ken Manning (Cephalon), Brian Johnson (Pfizer), Eric Berg (Amgen), Barb Unger (Amgen), Janice M. Soreth (FDA), Susanne Keitel (EDQM, Council of Europe), David Cockburn (EMA, not shown), Jack Brinnier (Watson), Janice Berger (Astra Zeneca) and Najib Sehat (Merck).