Thursday, September 02, 2010

Rx-360 is creating and monitoring a global quality system that assures patient safety by enhancing product quality and authenticity throughout the supply chain.
Invitation to Rx-360 Annual Meeting Minimize

Rx-360 will host an Open Meeting for all interested parties to learn more about the organization, its progress in 2010 and its 2011 plans.

The Rx-360 Open Meeting will take place on:

 Thursday, 16 September 2010
9:30 – 5:00 CET
Hosted by Merck KGaA
Frankfurter Str. 250
64293 Darmstadt, Germany 

The Open Meeting will include presentations by Rx-360 leaders and the following 3 Regulators: 

David Cockburn, Head of Manufacturing and Quality Compliance, EMA

Starting Materials:  EU Expectations and Current Developments

 

Dr. Susanne Keitel, Director, EDQM

EDQM’s Perspective and Lessons Learned on Globalization and the Challenges of Securing the Supply Chain

 

Dr. Janice Soreth, Deputy Director, Office of International Programs, U.S. FDA

FDA’s Collaboration with International Partners and Lessons Learned for Rx-360’s Initiatives

We encourage anyone interested in Rx-360 to join us at this meeting to learn more.

To register for this meeting, please go to: www.signmeup.com/71247

For additional information, please contact the Rx-360 Secretariat:

Kim Rouse
+1 202-230-5608

Note: There is no charge for this open meeting, but you must register by 3 September 2010 to assure your seat!

To download the meeting flyer click here 

To download the meeting agenda click here 
  

Rx-360 Summaries of Important Legislative and Regulatory Initiatives Minimize

U.S. Senate Proposed Legislation S.3690, Drug Safety and Accountability Act of 2010

On August 3, 2010 Senator Michael Bennet of Colorado introduced S. 3690 - the Drug Safety and Accountability Act of 2010.   After introduction it was referred to the Committee on Health, Education, Labor and Pensions.  This bill incorporates aspects of others which were previously introduced to Congress relative to drug safety.  Primary features of this bill include:
  • Expanding the definition of “adulteration” to include those drugs that do not comply with requirements in this bill to have and implement a Quality management plan and documentation of the drug supply chain.

    1. The Quality management plan requires periodic on-site audits by the company  Further, specifications and test methods must be sufficient “…to detect any hazard that has been, or is reasonably likely to be, present in or on the drugs during production, manufacturing, processing, packing, holding or transporting.” 
    2. The supply chain documentation “…shall show that the drug and the ingredients of the drug were manufactured, prepared, propagated, compounded, processed, and handled in a manner ensuring the identity, safety, quality, purity and strength of such drug.”  The supply chain documentation is to include “…names, addresses, phone numbers and GPS coordinates of each producer, manufacturer, distributor and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug…”.

  • FDA is to develop and maintain information systems that are capable of identifying and tracking drugs and their active ingredients.  FDA has one year after this bill is enacted to develop such systems.

  • FDA is not to consider whether products are OTC drugs in their decisions regarding timing and frequency of inspections

  • FDA is to pursue Mutual Recognition Agreements and report on progress to Congress

  • FDA is to have mandatory recall authority (similar to H.R. 5740 introduced July 14, 2010)

     
  • Criteria for assessing civil penalties

  • Whistleblower protection

Download / view the entire
Rx-360 summary click here

  Download / view S.3690 click here

 

U.S. H.R. 4678: Foreign Manufacturers Legal Accountability Act of 2010

 

HR4678 was introduced in February 2010 by United States Congressman Sutton and approved by the House Ways and Means Committee in July 2010.  The Energy and Commerce and House Agriculture Committees will now have the opportunity to consider the bill before it goes to the full House.  This is a companion bill to one that was introduced in the U.S. Senate (S. 1606) in August 2009 by Senator Whitehouse.  The purpose of the bill is to require foreign manufacturers, whose products are imported into the US, to identify “registered agents” who have responsibility to serve as the point of contact for communication of legal proceedings and actions.  Section 3(b) of the proposed legislation states that “A foreign manufacturer or producer of a covered product that registers an agent under this section thereby consents to the jurisdiction of the State and Federal courts of the State in which the registered agent is located for the purpose of any judicial proceeding related to such covered product.”  This will facilitate taking legal action against these manufacturers in the United States.  The bill is not specifically focused on products regulated by the FDA but also covers items governed by the Consumer Product Safety Commission, the Environmental Protection Agency and the National Highway Traffic Safety Administration. 

 

     download / view the Rx-360 summary click here

 

 

 

To read all summaries created by
Rx-360 click here

 
  

Interesting Supply Chain News Minimize
  

Pharmaceutical Cargo Security Coalition will host an educational seminar Minimize

The Pharmaceutical Cargo Security Coalition (PCSC) will be hosting its first educational seminar on September 28, 2010. The event will be centered around two "table-top exercises" - the first surrounding what to do if your company is notified you've been the victim of an in-transit cargo theft; the second will address what to do if you've been notified a warehouse belonging to you (or that contains your products) has been burglarized.  This seminar will be co-sponsored by both Pfizer and Freightwatch. 

 

Much like the military utilizes them, "table-top" exercises simulate real world situations - using role players from many different disciplines to simulate the critical responses necessary to effectively deal with these unfortunate events. The simulations we will conduct will be performed in a "theater in-the-round" which allows for the most effective audience participation and visibility. Those who have been actual victims in the past; those who have responded (or would respond) from a law enforcement prospective; as well as those that have insured products that have actually been stolen, will have all volunteered to be role players in this educational event. In a somewhat modified fashion from a pure table-top scenario, audience members will actively participate in each simulation and be allowed to ask questions as well as critique responses.  

 

Earlier this year a similar training exercise was held at an HDMA seminar and it was very well received.

 

This PCSC event will held at a Pfizer facility, located in Collegeville, Pennsylvania. There will be no cost to attend - other than personal travel and cost of lunch that day. Pfizer does have a very nice dining hall in the same building as the auditorium. There are also a number of hotels close to the event location - one located right on the Pfizer campus itself. Travel from the Philadelphia International Airport is estimated at 40 minutes.  This will be purely an educational event, no solicitations will be permitted. 

 

I am proposing the seminar run from 9:00 AM - 3:30 PM with the morning devoted to an in-transit cargo theft and the afternoon session dealing with a warehouse burglary. Attendance will be limited to 200 people. First preference will be afforded to those within the pharmaceutical industry and entities that support that industry.  If space is still available, other manufacturing disciplines may be considered as well.

 

Location:            500 Arcola Road

                         Collegeville, Pennsylvania

 

Time:                 9:00 AM - 3:30 PM 

 

Event Coordinators: 
Chuck Forsaith, Charles.Forsaith@pharma.com

Brad Elrod, Bradley.Elrod@pfizer.com

Andrea Johnson, Andrea.Johnson@freightwachintl.com
  

New Rx-360 Offerings Minimize
Training Aids: Need a training aid? Need to create a convincing argument for the need to secure the supply chain? Then Rx-360 has your answer.  A series of educational videos have been added to the Rx-360 web site that can be used for these very purposes.  Just click here to see what videos are available.  More videos are added all the time.
IPQ Inside the global regulatory dialogue

The New Issue of International Pharmaceutical Quality (IPQ)

IPQ is pleased to provide you with complimentary access to the inaugural issue of IPQ’s “Monthly Update” on key CMC/GMP developments in the US, Europe, and internationally. To access the issue, click here. 

 
  

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