Pharmaceutical Regulatory Affairs: Open Access

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Posters

• Spontaneous reporting of adverse drug reactions: An effective strategy for post-marketing drug regulation and safety surveillance

  Avong Yohanna Kambai, Bolajoko Oladunni Obembe, Petros Isaakidis, Sven Gudmund Hinderaker, Rafael Van den Bergh, Engy Ali, Ernest Ekong, Clement Adebamowo, Ndembi Nicaise, James Okuma, Adeline Osakwe, Olanrewaju Oladimeji, Gabriel Akang, Joshua Obasanya, Osman Eltayeb, Aderonke Agbaje, Charles Men

  PDF HTML

• Regulatory transparency: Technical, legal and ethical aspects of access to regulatory applications (medicines dossier) - Brazilian approach

  Varley Dias Sousa

  PDF HTML

• Have FDA expedited programs really shortened drug review time? an analysis of newly approved therapies and how FDA expedited programs have impacted drug development timelines

  Krasimira Pekova

  PDF HTML