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PDA Parenterals Conference

From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.

This outstanding event will cover the very important topics:

  • Future of Parenterals
  • Packaging and Impact on Quality
  • Manufacturing Flexibility and Control
  • Innovative Plants
  • Monitoring Technologies
  • Medical and Application Devices
  • Regulatory Trends

Don´t miss this interesting conference in Berlin, Germany.

Brochure of PDA Parenterals Conference 2010, October 26-28

 

News about GMP/cGMP

FDA Opens New Office in Mexico

FDA Expands Presence Outside U.S. with Opening of Mexico City Post the third in Latin America and the tenth internationally.

 

As part of its continuing effort to buttress food and medical product safety in this country by working with its regulatory partners overseas, the U.S. Food and Drug Administration this week announced the opening of its Mexico City post. This is the Agency’s third post in Latin America and its tenth international post in the past 13 months.

“The opening of this office represents an important step as we re-design our product safety strategy. We, like our partners in the Mexican Government, realize that prevention is the key. For example, more than a third of the fresh fruits and vegetables we eat come from Mexico as do a large amount of our medical devices. Having FDA experts located permanently there will be mutually beneficial to both our countries and respective citizens,” said U.S. FDA Commissioner Margaret A. Hamburg, M.D.

Staff assigned to the FDA’s Mexico City post will work with their counterparts in the Mexican government to harmonize regulations and guidance standards and to work on other collaborative initiatives. These collaborations will include, for example, information-sharing on the respective regulatory systems and joint workshops on the safety of food and medical products. Agencies in both governments also will make efforts to find opportunities for joint training on food-borne illnesses and the oversight of food traded internationally.

FDA staff also will offer collaboration on the use of the latest laboratory techniques, foster other collaborative initiatives to ensure the safety of food and medical products marketed in the two countries, and be a “portal” to the FDA for counterpart Mexican agencies and the US-export industry in Mexico.

“FDA staff will work with industry in Mexico as well,” said Murray M. Lumpkin, M.D., U.S. FDA Deputy Commissioner for International Programs. “FDA experts in Mexico City will work closely with local industries that ship food and medical products to the United States to improve their understanding of U.S. safety and product quality expectations. Their activities will include providing technical advice and working with government agencies and the private sector to develop certification programs.”

To date, the FDA has opened 10 international posts, including posts in China, India, Europe, and Latin America, along with its USA-based staff. The other posts in the Latin America Office are located in Santiago, Chile, and at the FDA’s Latin America Office headquarters in San José, Costa Rica.

Source: FDA Press Release

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