Good Clinical Practices and Good Laboratory Practices
The role of ICH in designing GCP principles is to provide an ethical treatment to the subjects who are involved in the clinical trials. Conference on Good Clinical Practices is important because it is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Pre-clinical trials assess the toxicity of a drug and examine its potential effects on the human body. These trials are conducted in-vitro which is required to proceed with clinical trials. Good laboratory practices should be followed for these pre-clinical trials.
- Role of ICH in designing GCP principles
- Principles of GLP in vitro Studies
- OECD guidelines for the testing of chemicals
- Good Laboratory Practices (GLP) for Pre-Clinical Testing
- IEC-GCP regulations
- Pre-clinical trails
- Clinical trails
- SAS programming, usage in pharmaceutical industry
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Good Clinical Practices and Good Laboratory Practices Conference Speakers
Recommended Sessions
- Pharmaceutical Audit
- Auditing Deviations, Product Complaints, and CAPA Systems
- Best Industry Practices
- Biologics & Biosimilars
- Clinical Affairs & Regulatory Strategies
- Contract and Sterile/Aseptic Manufacturing
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
- Current Regulations and Quality Standards
- Excipient Qualification and Supply Chain Controls
- Formulation Development
- Global Regulatory Intelligence
- GMP in Food Industry, Microbiology & Biotechnology
- Good Clinical Practices and Good Laboratory Practices
- Good Manufacturing Practices: The Gap Within
- Impact of Brexit on Regulatory Framework
- Intellectual Property Rights
- Medical Device & Combination Products Regulations
- Penalties for Regulatory Non-compliance
- Quality Control & Quality Assurance
- Quality Management System in Testing Laboratories
- Regulatory Affairs
- Regulatory Challenges for Medical Devices
- Regulatory Communications and Submissions
- Regulatory Requirements for Pharmaceuticals
- Softwares in GMP and GCP
- Storage, Distribution, Transportation
- Validation
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