Regulatory and Compliance Issues in Biotechnology
( 25 Modules )

Module #1
Introduction to Biotechnology Regulation
Overview of biotechnology regulation, reasons for regulation, and key stakeholders involved

Module #2
History of Biotechnology Regulation
Timeline of major events and milestones in biotechnology regulation

Module #3
Overview of Regulatory Framework
Key regulatory agencies, laws, and guidelines governing biotechnology in the US and EU

Module #4
FDA Regulations for Biotechnology Products
FDAs role in regulating biotechnology products, including drugs, biologics, and medical devices

Module #5
EPA Regulations for Biotechnology Products
EPAs role in regulating biotechnology products, including pesticides and genetically modified organisms

Module #6
USDA Regulations for Biotechnology Products
USDAs role in regulating biotechnology products, including genetically modified organisms in agriculture

Module #7
EU Regulations for Biotechnology Products
Overview of EU regulations for biotechnology products, including the EUs regulatory framework and key agencies

Module #8
Compliance Issues in Biotechnology Research
Compliance issues in biotechnology research, including Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs)

Module #9
Good Manufacturing Practices (GMPs) in Biotechnology
Overview of GMPs in biotechnology, including current Good Manufacturing Practices (cGMPs) and Good Distribution Practices (GDPs)

Module #10
Good Laboratory Practices (GLPs) in Biotechnology
Overview of GLPs in biotechnology, including principles and procedures for conducting non-clinical laboratory studies

Module #11
Regulatory Requirements for Clinical Trials
Regulatory requirements for clinical trials in biotechnology, including Investigational New Drug (IND) applications and Institutional Review Boards (IRBs)

Module #12
Genetic Engineering and Gene Therapy Regulations
Regulations for genetic engineering and gene therapy, including risks and benefits, and ethical considerations

Module #13
Stem Cell Research and Regulation
Overview of stem cell research, including regulatory issues and ethical considerations

Module #14
Synthetic Biology Regulation
Regulatory issues in synthetic biology, including risks and benefits, and ethical considerations

Module #15
Biosafety and Biosecurity in Biotechnology
Biosafety and biosecurity issues in biotechnology, including laboratory safety and Select Agent regulations

Module #16
Intellectual Property and Patenting in Biotechnology
Intellectual property and patenting issues in biotechnology, including patentability and licensing agreements

Module #17
Ethical Considerations in Biotechnology
Ethical considerations in biotechnology, including informed consent, privacy, and confidentiality

Module #18
Global Harmonization of Biotechnology Regulations
Efforts towards global harmonization of biotechnology regulations, including the International Conference on Harmonization (ICH)

Module #19
Regulatory Affairs in Biotechnology Industry
Role of regulatory affairs in the biotechnology industry, including regulatory strategy and submission planning

Module #20
Compliance and Enforcement in Biotechnology
Compliance and enforcement mechanisms in biotechnology regulation, including inspections and enforcement actions

Module #21
Biotechnology Product Labeling and Advertising
Regulatory requirements for labeling and advertising biotechnology products, including FDA guidelines and EU directives

Module #22
Post-Marketing Surveillance and Pharmacovigilance
Regulatory requirements for post-marketing surveillance and pharmacovigilance in biotechnology, including adverse event reporting and risk management

Module #23
Regulatory Issues in Biotech Partnerships and Collaborations
Regulatory issues in biotech partnerships and collaborations, including licensing agreements and joint ventures

Module #24
Emerging Trends and Future of Biotechnology Regulation
Emerging trends and future directions in biotechnology regulation, including precision medicine and gene editing

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory and Compliance Issues in Biotechnology career

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Regulatory and Compliance Issues in Biotechnology ( 25 Modules )

Regulatory and Compliance Issues in Biotechnology
( 25 Modules )