Regulatory Affairs in Clinical Research
( 25 Modules )

Module #1
Introduction to Regulatory Affairs in Clinical Research
Overview of regulatory affairs, importance in clinical research, and career opportunities

Module #2
History of Regulatory Affairs
Evolution of regulatory affairs, key milestones, and influencing factors

Module #3
Global Regulatory Framework
Overview of international regulatory bodies, such as FDA, EMA, and ICH

Module #4
Clinical Trial Regulations
In-depth review of regulations governing clinical trials, including ICH GCP

Module #5
Investigational New Drug (IND) Applications
IND application process, content, and submission requirements

Module #6
Institutional Review Boards (IRBs) and Ethics Committees
Roles and responsibilities of IRBs and ethics committees in clinical research

Module #7
Good Clinical Practice (GCP) and Compliance
Principles and guidelines of GCP, compliance, and quality management

Module #8
Regulatory Submissions and Correspondence
Preparing and submitting regulatory documents, such as INDs, NDAs, and appeals

Module #9
Clinical Trial Site Selection and Management
Site selection, site initiation, and site management best practices

Module #10
Informed Consent and Patient Recruitment
Informed consent process, patient recruitment strategies, and retention methods

Module #11
Adverse Event Reporting and Pharmacovigilance
Adverse event reporting, pharmacovigilance, and risk management

Module #12
Data Management and Biostatistics
Data management principles, biostatistics, and data analysis in clinical trials

Module #13
Regulatory Inspections and Audits
Preparing for and hosting regulatory inspections and audits

Module #14
Post-Marketing Surveillance and Pharmacovigilance
Post-marketing surveillance, pharmacovigilance, and risk management

Module #15
Regulatory Affairs in Special Populations
Regulatory considerations for clinical trials in pediatric, geriatric, and vulnerable populations

Module #16
Gene Therapy, Cell Therapy, and Tissue Engineering
Regulatory aspects of gene therapy, cell therapy, and tissue engineering

Module #17
Medical Devices and Combination Products
Regulatory requirements for medical devices and combination products

Module #18
Regulatory Affairs in Emerging Markets
Regulatory requirements and challenges in emerging markets, such as Asia and Latin America

Module #19
Regulatory Intelligence and Strategic Planning
Regulatory intelligence gathering, strategic planning, and decision-making

Module #20
Communicating with Regulatory Agencies
Effective communication strategies with regulatory agencies, including FDA and EMA

Module #21
Regulatory Compliance and Quality Assurance
Regulatory compliance, quality assurance, and quality control in clinical research

Module #22
Auditing and Monitoring Clinical Trials
Auditing and monitoring clinical trials, including on-site and remote monitoring

Module #23
Regulatory Affairs in Digital Health
Regulatory aspects of digital health, including mobile health and telemedicine

Module #24
Regulatory Career Development and Professional Certification
Career development opportunities and professional certification in regulatory affairs

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Affairs in Clinical Research career

WIZAPE

ONLINE RESOURCES

ABOUT WIZAPE

ONLINE PORTAL

Our priority is to cultivate a vibrant community before considering the release of a token. By focusing on engagement and support, we can create a solid foundation for sustainable growth. Let’s build this together!

We're giving our website a fresh new look and feel! 🎉 Stay tuned as we work behind the scenes to enhance your experience.
Get ready for a revamped site that’s sleeker, and packed with new features. Thank you for your patience. Great things are coming!

CONTACT-US PRIVACY POLICY

Regulatory Affairs in Clinical Research ( 25 Modules )

Regulatory Affairs in Clinical Research
( 25 Modules )