PharmaTrain | Mastering Medicine's Development PharmaTrain is implementing reliable standards for high-quality postgraduate education and training in Medicines Development. Training Centres, which offer Diploma Courses, Master Programmes as well as CPD Modules and training courses under the PharmaTrain brand share the high PharmaTrain standards and undergo quality assessments.
RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.

These Courses Are Available for RAPS Credits:

Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
Biostatistics for Non-Statisticians
Clinical Document Management - A Trial-by-Trial Approach to Compliance
Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices
CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
Comprehensive Overview of FDA Regulatory Compliance for Medical Devices
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
EU Quality Dossier Submission Requirements
European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements
European Union Regulatory Issues – New Product Development
FDA Inspections – What Regulators Expect & How to Prepare
Filing Variations in the European Union
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials
Good Clinical Practices (GCP) & Risk Based Monitoring- Understanding and Implementing Current Global Requirements
Good Manufacturing Practices
Introduction to Effective Medical Writing
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, Biosimilars, Post-Approval Supplements)
Preparing the CMC Section for MAAs-IMPDs
Preparing the CMC Section for NDAs-CTDs-INDs
Project Management for Medical Device Product Development
Selecting and Managing CRO's
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
The Drug Development Process - From Discovery to Commercialization
The Electronic Common Technical Document(eCTD): Strategies & Tools to Build a Successful Submission
Validation of Computer Systems