Regulatory Affairs in Biopharmaceuticals
( 30 Modules )

Module #1
Introduction to Regulatory Affairs in Biopharmaceuticals
Overview of the role of regulatory affairs in the biopharmaceutical industry, importance of compliance, and key stakeholders involved.

Module #2
Global Regulatory Framework
Comparative overview of regulatory frameworks in major regions (US, EU, Japan, China) and international harmonization initiatives.

Module #3
FDA Regulations and Guidances
In-depth review of FDA regulations, guidances, and laws governing biopharmaceutical development and approval.

Module #4
EMA Regulations and Guidances
In-depth review of EMA regulations, guidances, and laws governing biopharmaceutical development and approval in the European Union.

Module #5
ICH Guidelines and Harmonization
Overview of International Conference on Harmonisation (ICH) guidelines and their impact on global biopharmaceutical development and approval.

Module #6
Good Manufacturing Practices (GMPs) and Quality Systems
Understanding GMPs, quality systems, and quality control in biopharmaceutical development and manufacturing.

Module #7
Clinical Trial Regulations and Ethics
In-depth review of clinical trial regulations, ethical considerations, and good clinical practice (GCP) guidelines.

Module #8
Investigational New Drug (IND) Applications
Preparation, submission, and management of IND applications, including content and formatting requirements.

Module #9
New Drug Applications (NDAs) and Biologics License Applications (BLAs)
Preparation, submission, and management of NDA and BLA submissions, including content and formatting requirements.

Module #10
Regulatory Submissions and eSubmissions
Understanding electronic submissions, eCTD, and other formats for regulatory submissions.

Module #11
Regulatory Strategies and Planning
Developing effective regulatory strategies, including regulatory intelligence, gap analysis, and project planning.

Module #12
Labeling and Packaging
Understanding labeling and packaging regulations, including content, formatting, and distribution requirements.

Module #13
Post-Marketing Surveillance and Pharmovigilance
Understanding post-marketing surveillance and pharmovigilance requirements, including adverse event reporting and signal detection.

Module #14
Compliance and Enforcement
Understanding compliance and enforcement mechanisms, including FDA inspections, warning letters, and fines.

Module #15
Regulatory Affairs in Gene and Cell Therapy
Unique regulatory considerations for gene and cell therapy products, including CMC and clinical trial requirements.

Module #16
Regulatory Affairs in Combination Products
Unique regulatory considerations for combination products, including drug-device and biologic-device combinations.

Module #17
Global Regulatory Pathways for Orphan and Rare Diseases
Understanding global regulatory pathways for orphan and rare diseases, including FDA orphan drug designation and EMA priority medicines.

Module #18
Real-World Evidence and Regulatory Decision-Making
Understanding the role of real-world evidence in regulatory decision-making, including its application in marketing authorization and post-marketing surveillance.

Module #19
Artificial Intelligence and Machine Learning in Regulatory Affairs
Understanding the application of artificial intelligence and machine learning in regulatory affairs, including data analytics and risk-based approaches.

Module #20
Regulatory Affairs in Digital Health and Medical Devices
Unique regulatory considerations for digital health and medical devices, including software as a medical device (SaMD) and mobile medical applications.

Module #21
Regulatory Intelligence and Competitive Analysis
Understanding regulatory intelligence and competitive analysis, including competitor landscaping and gap analysis.

Module #22
Regulatory Audit and Inspection Readiness
Preparing for regulatory audits and inspections, including readiness strategies and corrective action plans.

Module #23
Regulatory Crisis Management and Communication
Developing effective crisis management and communication strategies for regulatory issues and product recalls.

Module #24
Global Regulatory Affairs Best Practices
Understanding global regulatory affairs best practices, including risk-based approaches, quality systems, and compliance.

Module #25
Regulatory Affairs in Emerging Markets
Understanding regulatory affairs in emerging markets, including Brazil, Russia, India, China, and South Africa (BRICS).

Module #26
Regulatory Affairs in Advanced Therapies
Unique regulatory considerations for advanced therapies, including gene editing and regenerative medicine.

Module #27
Regulatory Affairs in Personalized Medicine
Unique regulatory considerations for personalized medicine, including companion diagnostics and pharmacogenomics.

Module #28
Regulatory Affairs in Vaccines and Infectious Diseases
Unique regulatory considerations for vaccines and infectious diseases, including pandemic preparedness and response.

Module #29
Regulatory Affairs in Oncology and Hematology
Unique regulatory considerations for oncology and hematology, including accelerated approval and breakthrough therapy designation.

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Affairs in Biopharmaceuticals career

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Regulatory Affairs in Biopharmaceuticals ( 30 Modules )

Regulatory Affairs in Biopharmaceuticals
( 30 Modules )