Malvern, PA - May 30, 2013 - The Center for Professional Innovation and Education (CfPIE) has introduced four new training courses for pharmaceutical, biotechnology, and medical device professionals, which include:
Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices. This Food and Drug Administration (FDA) Good Clinical Practice (GCP) course reviews all phases of clinical drug development and focuses on best practices to remain compliant with GCP guidelines and FDA regulations.
Biosimilars: Understanding Regulatory Challenges. This course examines the Chemistry, Manufacturing and Controls (CMC), nonclinical and clinical regulatory requirements from FDA, European Medicine Agency (EMA), and World Health Organization (WHO) for biosimilar biological products.
Advanced Topics for Biostatistics for Non-Statisticians. This course focuses on the statistical requirements of health science research, while addressing their effect on clinical studies.
Navigating Latin American Regulatory Compliance Requirements for Clinical Trials. This regulatory compliance course introduces the regulatory landscape in Argentina, Brazil, Chile and Peru, as well as the matrix of agency requirements that affect compliance.
The new courses provide versatile options for life science professionals to stay ahead of industry regulations, enhance cross-discipline exposure, meet professional development and certification requirements, and capitalize on personal career growth opportunities.
Each course is associated with one of CfPIE’s eleven industry-recognized certification tracks, which are offered at no additional cost above standard course fees. CfPIE’s certification program provides flexibility to choose between three core courses and one elective course to meet the diverse needs of life science professionals. All certification tracks are developed and vetted by a committee of industry experts, many whom are former FDA or international regulators.
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