IPAC-RS

Global Regulatory Review Outreach (GRRO)

We seek to understand, report on, and analyze existing and developing legislation, regulations, and guidances around the world that are relevant to OINDP and IPAC-RS members. We also reach out internationally to industry and facilitate working relationships with regulatory bodies abroad in order to further the common interest of the OINDP industry.

GRRO activities include supporting and/or driving consortium comments on international guidelines and standards and leading IPAC-RS efforts to liaise with industry or government organizations.  The Group’s main activities are focused on Brazil and China through its China and Brazil Subgroups, however the GRRO addresses general industry and regulatory outreach as needed throughout the year.

The Group also oversees production of the World Bulletins reporting on regulatory systems and relevant policies in various countries and maintenance of the International Regulatory Compendium for the benefit of IPAC-RS members.

News

Global Regulatory Review and Outreach Update

The Global Regulatory Review and Outreach (GRRO) Working Group and the Board of Directors formed a GRRO EU team early in 2015 to focus on regulatory matters and outreach related to EU member states and EMA.  This team joined the GRRO Brazil, China, and ad hoc Turkey group in the portfolio of GRRO activities.  GRRO group leadership will hold regular teleconferences to help develop overall strategies and exchange information on group activities.

Publications

An IPAC-RS Update: Delivery Systems, L&E and GRRO

By Working Group: Global Regulatory Review Outreach (GRRO). By Working Group: Leachables and Extractables (L&E) Development Paradigm Knowledge Network. By Working Group: Device. Ilse Peterson, Svetlana Lyapustina, and Lee Nagao Article, Inhalation (published)

Comments on Guidances

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