Janeen Skutnik

I have extensive, broad-based experience in the Pharmaceutical Industry covering areas such as Quality Systems, Quality Strategy, external advocacy (working with governments, regulators and trade associations globally), managing documentation and change control systems, Pharmacopoeial (Compendial Affairs) (including setting up compendial programs for two companies), I have over 15 years of experience working with PhRMA and IPEC Trade assocations. I have served as the chair person of several teams within various trade associations and am currently the chair of the IPEC (International Pharmaceutical Excipients Council) Trade Association. I have also been the PhRMA topic Leader on the ICH Q4B EWG. Specialties: Quality Systems, Quality Strategty, Regulatory Affairs, Quality Control, External Advocacy, Project Management, Influencing the External Environment, Documentation and Change Control, Quality Risk Management, Excipients, Pharmacopoeial Harmonisation, Pharmacopoeial (Compendial) Liaison.