 The Clinical Compliance Certified Professional (CCCP) program is ideal for individuals involved in the clinical stages of drug development. This curriculum is designed to give participants a thorough, practical understanding of all clinical phases from both a regulatory and procedural perspective. Attendees will gain comprehensive insight into early drug development, the role of the FDA and other regulatory bodies and the requirements of trial monitoring and reporting adverse events - pre and post approval.
NEW! Program now customizable for those in the Medical Device field!
CfPIE is pleased to announce revisions to the CCCP track which allow Medical Device professionals to customize this program to suit their individual needs. Now personnel in the Pharmaceutical, Biotech and Medical Device industries can work towards a professional certification to help them face their own specific clinical trials challenges.
Select three core courses and one elective from the list below. Your elective course should best reflect your area of responsibility:
Core Courses (Choose Three):
- NEW! Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements
- NEW! Good Monitoring Practices for Medical Devices
- NEW! Clinical Trials Design For Medical Devices
- The Drug Development Process - From Discovery to Commercialization
- Good Clinical Practices (GCP)
- Adverse Drug Events – Understanding and Reporting Requirements
- How to Monitor Clinical Trials for GCP Compliance
- The EU Clinical Trial Directive
Elective Courses (Choose One):
- NEW! Detecting Fraud and Misconduct in Clinical Trials
- NEW! Improving Investigator Site Performance
- NEW! Maximizing Global Patient Recruitment and Retention
- Project Management for Phase 1 & 2 Clinical Trials
- Introduction to Effective Medical Writing
- Writing Effective Standard Operating Procedures and Other Process Documents
- Project Management for Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
- Biostatistics for Non-Statisticians
- Validation of Computer Systems
- cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
- Selecting & Managing CRO’s
- FDA Inspections of Clinical Data Systems
- European Filing and Registration Procedures
Please contact CfPIE at +1-610-688-1708 or via email info@cfpie.com.
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