Small Organizations, Big Regulatory Strategy
By Angela Johnson, MSE, PMP, RAC -
Published 30 January 2017
This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulatory programs with a strong underlying alignment with business development.
Categories: Features, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration
Tags: Regulatory Strategy, SMEs
Out of Africa: Six Regulatory Articles that Span the Continent
By Janet Aker, Managing Editor, Regulatory Focus -
Published 16 February 2015
Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.
Categories: Features, Africa, Drugs, Government affairs, Project management, Submission and registration
Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante