The Clinical Sciences certificate program is designed to enable those playing critical roles in the biopharmaceutical development process gain a thorough understanding of relevant regulations and guidelines, as well as a practical, real-world approach to conducting safer and more efficient clinical trials.
This educational track is designed for clinical professionals working as:
To earn the certificate, you must complete THREE core courses and ONE elective course from the list below. Courses must be completed within five years to remain eligible for earning a PERI certificate. Once you have completed the required courses, contact the PERI Registrar for validation, and the Clinical Sciences certificate will be mailed to you. If you have questions about your progress, contact PERI at firstname.lastname@example.org.
- Basic Pharmacology Blended Online CourseOpen or Close
This new foundational online blended program pairs the newly revised Pharmacology Online distance education program with weekly webinars, case studies and online discussions to enhance learning and retention of key basic research information.
- Basic Drug Development: Overview of Biopharmaceutical Research & DevelopmentOpen or Close
In a blending of online and live learning, this course provides an overview of the process and issues common to all new chemical entity (NCE) development projects, from the research and development stages through product launch and post-marketing safety.
Next Offering:November 16-17, 2017 – Arlington, Virginia, USA
- Biologics and Biosimilars: An Integrated Overview of Product DevelopmentOpen or Close
Gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics and biosimilars.
- Global Pharmacovigilance Training ProgramOpen or Close
This course focuses on global regulatory requirements required for the management of product safety data from clinical trial and postmarket sources.
- Prescription Drug Labeling Regulations: US, Canada, EUOpen or Close
This course provides a detailed review of the legal and regulatory principles driving prescription drug labeling and patient labeling in the US, Canada and the EU.
- Applied Good Clinical PracticesOpen or Close
This online course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide.
- Clinical Monitoring and Site ManagementOpen or Close
The goal of this online course is to provide a practical orientation to site management and monitoring of clinical studies.
- Decision Points in Pharmaceutical DevelopmentOpen or Close
This introductory web-based module focuses on the critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch.
- GCP for the Clinical Research Team seriesOpen or Close
This virtual series is different from many other courses in that its perspective is from that of the site based investigator rather than the sponsor. All three courses must be completed in the series for credit.
- Pharmacology OnlineOpen or Close
This online course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development.
- Statistics Concepts Used in Clinical TrialsOpen or Close
This online course reviews statistical terminology, provide an understanding of statistics, and explain trial design from a clinician’s viewpoint.
- Cancer: Pathophysiology, Current Therapies, Clinical Trials, and Drug DevelopmentOpen or Close
This course provides an overview of human cancer with discussions of specific cancer types, current therapeutics and design of clinical trials.
Next Offering:October 25-27, 2017 – Washington, DC, USA
- Introduction to Global Regulatory Affairs: Overview of Pharmaceuticals & BiologicsOpen or Close
This course provides a comprehensive overview of US, European, Canadian, Japanese and Rest-of-World (ROW)/ Emerging Market regulations for drug and biologic development from pre-clinical to post approval.
- Implementing Effective Global Clinical Trial Management and OperationsOpen or Close
This course addresses clinical trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry.
- Oncologic Development Strategies: Protocol DevelopmentOpen or Close
This course covers oncologic clinical trials from Phase I through Phase III with discussions of relevant design, ethical and regulatory issues, as well results of complex trials.
- Pharmacokinetic Concepts in Drug DevelopmentOpen or Close
This course provides an intuitive approach to pharmacokinetic (PK) concepts, using easily understood mathematical and descriptive teaching methods.
- Project Management in the Research-Based Pharmaceutical IndustryOpen or Close
This course addresses project management issues and skills needed to wisely choose and effectively develop new therapies in today’s global climate.
Next Offering:September 28-29, 2017 – Waltham, Massachusetts, USA
- Regulation of Marketing and Promotion of Prescription DrugsOpen or Close
This course presents industry and FDA experts on current issues regarding FDA regulation of promotional activities such as direct-to-consumer advertising, social media, scientific exhibits, off-label communications as well as trends in FDA enforcement.