Regulatory Affairs
Pharmacovigilance
Medical Coding
Computer Aided Drug Design (CADD)
Computerized System Validation (CSV)
Introduction to Pharmaceutical Science
- Introduction to Pharmaceutical Labelling
- Introduction to GMP in Pharma Industry
- Introduction to European Medicines Regulation - Free
- Introduction to Regulatory Affairs
- Introduction to Pharmacovigilance
- Introduction to Quality Management System
- Introduction to Medical Devices
- Introduction to Clinical Trials
- Introduction to Medical Writing
- Introduction to Medical Coding
- Introduction to Clinical Data Management
About Courses
Pharmaceutical companies are tightly regulated, with stringent government regulations to safeguard public health. The top priority of the pharmaceutical industry is to create and market a Drug that satisfies regulatory criteria. Drug development, manufacturing, and marketing all have varying aims. It must ensure safe and effective pharmaceutical formulations get to consumers promptly and prevent ineffective/dangerous/hurtful medicines from reaching patients.
A drug regulatory authority must ensure the safety, efficacy, and quality of all pharmaceuticals sold in its nation. The main challenge for the regulatory expert is to make sure that medicines are produced according to local rules, which includes examining key aspects throughout drug product development.
Entry Level Certification Course on Regulatory Affairs is designed to provide you with a detailed understanding of the various stages involved in drug development, from pre-clinical to post-marketing. In contrast, the Regulatory Affairs Certification Course for Professionals covers all aspects of drug regulation, from clinical trials to product approval and post-marketing surveillance
ENTRY LEVEL CERTIFICATION COURSE ON REGULATORY AFFAIRS
Description
This course will provide a comprehensive overview of the regulatory landscape relevant to the pharmaceutical and biotechnology industries. The focus of the course is on providing an understanding of the principles governing drug development and approval, as well as key aspects of regulatory compliance. It also includes ICH guidelines, CTD and eCTD modules, introduction to DMF, ASMF, and CMC, process validation, and product quality.
Courses Outcomes
Upon finishing this course, you will be able to:
- Understand the principles governing drug development and approval
- Understand the key aspects of regulatory compliance
- Write regulatory documents to communicate a company’s policies.
- Create a Regulatory Strategy that aligns with company goals and interests.
- Market pharmaceutical products in different countries with the proper licensing.
- Take on the role of entry-level Regulatory Affairs professional with ease.
Who Should Attend
This training is for pharmaceutical and biotech business professionals who are involved in regulatory affairs, such as QA/QC, R&D, production, and marketing. Students (B. Pharma/ M. Pharma/ B.Sc./M.) with a background in the pharmaceutical and healthcare sector..
CERTIFICATION COURSE FOR PROFESSIONALS AND GRADUATES ON REGULATORY AFFAIRS
Description
This course covers all aspects of drug regulation, from clinical trials to product approval and post-marketing surveillance in different countries. It provides a detailed understanding of DRA objectives, processes, and procedures. It includes ICH, eCTD, MDSAP, DCP, NDA, CMC, etc. The course also includes a 3-month internship at Sunshine Consultancy London Limited to provide you with the opportunity to gain hands-on experience in the regulatory affairs field.
Courses Outcomes
Upon finishing this course, you will be able to:
- Understand the objectives, processes, and procedures of Drug Regulatory Authorities (DRA)
- Understand, define and apply regulatory laws, guidelines, and procedures
- Prepare and submit regulatory documents such as IND, NDA, ANDA, etc.
- Conduct risk-benefit analysis and make sound regulatory decisions
- Prepare for and manage clinical trials
- Communicate effectively with clients, management, and health authorities
- Prepare and submit regulatory documents according to ICH, eCTD, MDSAP, and DCP guidelines
- Gain hands-on experience in the regulatory affairs field through an internship at Sunshine Consultancy London Limited.
- Take on the role of Regulatory Affairs Professional with ease.
Who Should Attend
This course is for professionals who want to take on a leadership role in regulatory affairs. It is also for those who want to specialize in a particular area of regulatory affairs, such as clinical trials, product approval, or post-marketing surveillance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc) with a background in the pharmaceutical and healthcare sector can also attend this course.