Emeryville, CA (Vocus/PRWEB) April 19, 2011
BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its President and CEO, Sally Van Doren, PharmD, will serve with a panel of experts at the BayBio 2011 Annual Conference/Powering Global Innovation held at the Hyatt Regency, SFO in Burlingame, CA. The session titled “The Regulatory Environment”, will be held April 20, 2011, 2:30pm - 3:45pm and will deal with the navigation and complexities of regulatory approval abroad.
As US-based companies are looking for commercial opportunities abroad for their novel products, they need to be aware of the regulatory environment in Europe, Asia and Latin America. While regulation is a very efficient process in the European Union, national regulatory agencies in Asia require a lot more effort, time and expense to gain approval. Even within regions time and costs vary greatly and are determined not only by the approval process, but also by administrative reasons.
The panel will address the following questions:
- What are the key differences between regulatory approval process in emerging and developed markets?
- What markets are more difficult in terms of regulatory approval?
- What are some of the strategies that worked for the Northern California companies that recently gained regulatory approval abroad
Dr. Van Doren will speak on drug and biologic safety regulatory differences and challenges in developed countries and developing regions.
Northern California regarded as a global innovation engine, the BayBio2011 Annual Conference will explore themes and topics that focus on fostering global collaborations in research, development and commercialization.
Founded in 2007 with a strong vision of a progressive drug safety and pharmacovigilance consulting services and education, BioSoteria serves the outsourcing needs of the pharmaceutical industry. From strategic risk management consulting services and full-service drug safety operational capabilities to world-class award winning pharmacovigilance training and education programs, BioSoteria provides unmatched experience, expertise, and leadership to support your company’s efforts to maximize your product’s benefit-risk profile. For more information and to learn more about BioSoteria’s drug safety services and training programs, go to http://www.biosoteria.com.