Symposium to highlight how legislation in Europe and U.S. can help bring medicines to market

“Regulatory Challenges for Orphan Medicines,” a symposium that features presentations by a number of industry experts, will take place during the DIA 2014 50th Annual Meeting at the San Diego Convention Center from June 15 to 19.

The symposium, held June 18 at 3:30 p.m., will focus on the regulatory environment and trends for orphan medicinal products around the world. Discussions will also include how companies can use the orphan drug legislation in Europe and the U.S. to support development of these products for markets outside of International Conference on Harmonisation regions.

“Our annual meeting is a global platform that offers holistic and integrated approaches for the life cycle management of regulated health care products,” said Barbara L. Kunz, DIA global chief executive. “This symposium embodies our approach by uniting diverse perspectives to better inform our members of how to bring orphan medicines to patients.”

The symposium includes an industry perspective of the regulatory challenges and opportunities for global development of orphan medicinal products given by Martine Zimmermann, vice president of global regulatory affairs for Alexion Pharmaceuticals, Inc. Isabel Zwart, senior regulatory consultant for Parexel, will discuss the role of orphan drug legislation in emerging markets, and Dr. Jordi Llinares, head of product development scientific support for the European Medicines Agency, will conclude with his perspective of the regulatory challenges for orphan medicines.

Contact: Tiffany Cohen
+1.202.499.4411
tcohen@reingold.com

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