- Introduction to Clinical Research
- Terminologies in Clinical Research
- Advantages of CR in India
- Introduction to Clinical Research- Notes
- Introduction to Clinical Research Quiz
Regulatory Affairs Courses Details:
TechnoBridge provides best Regulatory Affairs Courses with 100% placement assistance in Pune. The syllabus of the Regulatory Affairs Courses in Pune is developed by experienced industry experts. The course content is designed as per the ongoing needs and regulations of clinical research. TechnoBridge gives 100 % job assistance to the candidates. Students get many opportunities for jobs as well as a business once they complete their Regulatory Affairs Courses in Pune Successfully.
TechnoBridge is the Best Regulatory Affairs Training institute in Pune That covers all the essentials as per the standard guidelines. It includes the Drug Development, Introduction to GCP, Introduction to Regulatory Affairs, Regulatory Bodies (FDA, CDSCO), Application and Approvals (Drug and Device), Quality Assurance in RA, Design of trials, Privacy and Confidentiality, and Safety Reporting.
Practical Regulatory Affairs Courses for Professionals & Job Seekers
TechnoBridge offers Expert Designed Practical Regulatory Affairs Courses for Professionals & Job Seekers. All our candidates pursue regulatory affairs training programs for different reasons. For professionals, it is an add-on to their existing skillset. CRO owners can use these skills to enhance their business. Whereas these skills help job seekers get a job. Therefore, our courses are structured to meet the needs of different students.
Practical Regulatory Affairs Courses for Professionals & Job Seekers
TechnoBridge offers Expert Designed Practical Regulatory Affairs Courses for Professionals & Job Seekers. All our candidates pursue regulatory affairs training programs for different reasons. For professionals, it is an add-on to their existing skillset. CRO owners can use these skills to enhance their business. Whereas these skills help job seekers get a job. Therefore, our courses are structured to meet the needs of different students.
How to Enroll Regulatory Affairs Courses?
Online Application:
Candidates can easily apply directly on our website for Regulatory Affairs courses with 100% placement assistance. Our team will receive your application and help you with further processes. Additionally, Candidates can directly call our admission officers on the official contact number +91-9257035703.
Regulatory Affairs Course Fees:
Our Regulatory Affairs Courses Fee is just 20000/-.
Regulatory Affairs Course Key Features
- Learn From Corporate Experts / Faculty
- 100% Placement assistance
- Best and Affordable Price
- Life Time Access to The Course
- Detailed Curriculum
- Mock Interviews
- Flexible Batch Timings
- Trained 25000+ Students
Regulatory Affairs Courses Content [Updated 2023]
Introduction to Clinical Research
Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
Safety Reporting
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unblinding of Drug
- Clinical Safety and Pharmacovigilance
Application, Approval And Quality Assurance in RA
- Application of Permission
- Approval of Clinical Trial
- Purpose of QA
- Responsibility of Quality Function
- Medical Devices
Drug Development Process
- Overview of Drug Development
- Clinical trial phases
- BA/BE Studies
- Drug Development Notes
- Drug Development Quiz
Design of Trials
- Introduction Medical Writting 1
- Drafting a study protocol
- CRF Design
- Study Design
- Informed Consent
- Trial Master File
Introduction to RA And Regulatory Bodies
- Introduction to Regulatory Affairs
- International Regulations and Initiatives
- CDSCO
- FDA – Food & Drug Administration
- FDA- An Introduction
- CFR
- CT_Rules_2019
- ICMR Guidelines
Privacy and Confidentiality
- Privacy and Confidentiality
- HIPPA
- Informed Consent Privecy
- IRB's Role in Protecting Privacy
- Data Protection
Why Choose TechnoBridge for Regulatory Affair Courses?
In the Regulatory Affairs Certification program at TechnoBridge you’ll get the opportunity to
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Learn From Corporate Experts:
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Best and Affordable Price:
100% Placement Assistance
Life Time Access to The Course:
Study from experienced professionals of 25+ years of expert involvement with the business and rank among the most achieved in the worldwide regulatory affairs market.
Keep awake to date on advancing worldwide regulatory systems and industry patterns through ALERT, a worth add a program for understudies and graduated class, which highlights speakers from a scope of regulatory enterprises and furthermore gives professional advancement administrations to understudies at all phases of their vocations.
Associate with our Regulatory Affairs Courses with placement that works at the world's biggest drug, biologic, clinical gadget, nutraceutical, and cosmeceutical item and administration.
This is the one time pay and lifetime accessable course. The course will enable students to create regulatory documents and develop content for regulatory documents.
Regulatory Affairs Salary & Certification :
The job salary varies from profile to profile. An average salary package after completing the Regulatory Affairs course is 1.8L to 4.8L annually.
TechnoBridge provides a certificate after completing the PG Diploma in Regulatory Affairs successfully. Students must have 90% attendance along with good results in the exam.
What are Future Career Opportunities In Regulatory Affairs in India
Clinical research is the approach to propelling information about wellbeing, sickness, and medical care. There are different sorts of contemporary profession choices which you will get in this field. The clinical business is filling dramatically in India and the development will be increment ever later. A few positions in Clinical research are rattled off beneath. We provide highly challenging and rewarding careers in -
- Regulatory Affairs Executive
- RDrug egulatory Affairs Associate (CRA)
- Regulatory Affairs Consultant
- Drug safety or food safety officer
- Medical & Regulatory officer
- Quality Assurance Executive RA
- Medical Coding
- Medical writer
- Drug Inspector
- Manager –Safety / Patents
- Data Analyst Pharmacovigilance
- Clinical Trial/ regulatory Assistant (CTA)
- Medical Information Associate
- Project manager
- Clinical trial writer
Benefits of our Regulatory Affairs Courses
In the Regulatory Affairs Certification program at TechnoBridge you’ll get the opportunity to:
❖ The Regulatory Affairs Programme at TechnoBridge have the following enticing elements which clearly help the students of the course
❖ Expansive data, obviously focusing on the medical services industry
❖ Effectively organized course, cleverly set up under the direction of industry specialists from the same field
❖ Easily accessible simple to use, peruse and investigate e-tools woven astoundingly into the course make the review material, addresses, online data set, assessments, modules, and test papers.
Start Regulatory Affairs Career in Below Sectors:
Yes, the Regulatory Affairs industry is definitely booming and growing at an exponential rate. Nonetheless, one should know the respective sectors in the Regulatory Affairs industry. Listed below are the sectors you can work after completing Regulatory Affairs Courses:
- Pharmaceutical Companies
- Biotechnology Company
- Clinical Data Management Companies
- Pharmacovigilance Centers
- IT Companies in Healthcare
- Clinical CRO(Contract Research Organization)
- Data Management CROs
- Packaging Labeling and Contract Manufacturers
Companies and Clients for Regulatory Affairs:
Candidates who have completed Regulatory Affairs OR Pharmacovigilance Courses will be place in the following sectors:
- Sciformix
- TCS
- Cognizant
- Springer Nature
- Cotivity
- Lupin
- Docplexus
- 3Gen Consultancy
- Augustus
- Accutest
- Iqvia
- Access Healthcare
- Emcure Pharmaceuticals
Our Placement Process
Eligibility Criteria
Placement Training
Interview Q & A
Resume Preparation
Aptitude Test
Mock Interviews
Scheduling Interviews
Job Placements
Course Review
Frequently Asked questions
1. What is Regulatory Affairs?
Regulatory Affairs is a branch of clinical research that has great opportunities for a career. There are different periods of clinical research from the production of the medication. The pharmaceutical regulatory affairs courses open numerous career opportunities for clinical research experts at various stages of drug development unlimited professions. Regulatory affairs (RA) researchers are engaged with supervising the most common way of helping medication or items through the FDA survey and endorsement process and onto the market. Since each progression during the time spent item advancement is exceptionally directed, those in RA work at each progression to move medication from innovative work through FDA endorsement.
2. What are Regulatory Affairs in Clinical Research?
Regulatory affairs in the clinical trial are portions of the biotech channel that come after disclosure research and before the product can be utilized out on the planet along these lines, researchers in regulatory and clinical professions are significant entryways. The primary reason for this segment is to protect individuals. The researchers do this by deciding the signs, portion, and treatment populace through clinical preliminaries. Regulatory affairs do this by liaising among organizations and wellbeing specialists. There is a wide scope of occupations inside this area, all objectives arranged toward fostering that can emphatically affect the world. The PG Diploma in Regulatory Affairs is worthwhile, has great job security. It gives pathways to numerous other vocation fields and has many opportunities for those with MDs or PhDs.
- • PV Specialist
- • Researcher
- • PV/ Drug Safety Associate
- • Team Lead
- • Manager
- • Data Manager
- • Project Manager
3. Where do Candidates find Regulatory Affairs career opportunities?
Candidates who have completed Regulatory Affairs Courses will be placed in the following sectors:
4. Is Regulatory Affairs Course demo Session free?
Yes, demo Session is free of cost where we give an overview regarding the teaching methods and techniques.