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Best Regulatory Affairs Courses in Pune with 100% Placement

Regulatory Affairs
Duration
90 Days
Category
UI/UX Design
Rating

Regulatory Affairs Courses Details:

TechnoBridge provides best Regulatory Affairs Courses with 100% placement assistance in Pune. The course syllabus of the Regulatory Affairs Courses in India 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.


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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.


Regulatory Affairs Courses Content

Introduction to Regulatory Affairs

Clinical Data Management

Good Clinical Practice (GCP)-ICH E6

Monitoring of Trials

Pharmacovigilance

Regulatory Affairs

Protocol Designing

Drug Development Process


Why Choose TechnoBridge for Regulatory Affair Courses?

In the Regulatory Affairs Certification program at TechnoBridge you’ll get the opportunity to


❖ Learn From Corporate Experts:

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.


❖ Best and Affordable Price:

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.


❖ 100% Placement Assistance

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.


❖ Life Time Access to The Course:

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.


Benefits of our Regulatory Affairs Courses

❖ 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.


❖ E-apparatuses make the course independent and online tests make things more straightforward and less confounded for the members.


What is Regulatory Affairs Courses Eligibility & Duration?

The duration of online regulatory affairs Courses is 3 months at TechnoBridge. Candidates should have a minimum of 45% in his graduation. Candidates holding the following degrees are eligible to apply for this course:


    • Any degree in Life Science or BioScience
    • Any degree in Medicine
    • Any degree in Pharmacy or Pharmaceutical Sciences
    • Any degree in Nursing or Allied Health

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.


Fee For Regulatory Affairs Courses:

Our Regulatory Affairs Courses Fee is just 20000/-.


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 -


  1. • Regulatory Affairs Executive
  2. • RDrug egulatory Affairs Associate (CRA)
  3. • Regulatory Affairs Consultant
  4. • Drug safety or food safety officer
  5. • Medical & Regulatory officer
  6. • Quality Assurance Executive RA
  7. • Medical Coding
  8. • Medical writer
  1. • Drug Inspector
  2. • Manager –Safety / Patents
  3. • Data Analyst Pharmacovigilance
  4. • Clinical Trial/ regulatory Assistant (CTA)
  5. • Medical Information Associate
  6. • Project manager
  7. • Clinical trial writer
  8. • Data Analyst Pharmacovigilance

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:


  1. • Pharmaceutical Companies
  2. • Biotechnology Company
  3. • Clinical Data Management Companies
  4. • Pharmacovigilance Centers
  1. • IT Companies in Healthcare
  2. • Clinical CRO(Contract Research Organization)
  3. • Data Management CROs
  4. • Packaging Labeling and Contract Manufacturers

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.

Regulatory Affairs Course Syllabus:

Introduction to Clinical Research

  • • Introduction to Clinical Research
  • • Terminologies in Clinical Research
  • • Advantages of CR in India
  • • Introduction to Clinical Research- Notes
  • • Introduction to Clinical Research Quiz

Drug Development Process

  • • Overview of Drug Development
  • • Clinical trial phases
  • • BA/BE Studies
  • • Drug Development Notes
  • • Drug Development Quiz

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

Introduction to Regulatory Affairs And Regulatory Bodies

  • • Introduction to Regulatory Affairs
  • • International Regulations and Initiatives
  • • CDSCO
  • • FDA- An Introduction
  • • FDA – Food & Drug Administration
  • • CFR
  • • CT_Rules_2019
  • • ICMR Guidelines

Design of Trials

  • • Introduction Medical Writting 1
  • • Drafting a study protocol
  • • CRF Design
  • • Study Design
  • • Informed Consent
  • • Trial Master File

Application, Approval And Quality Assurance in RA

  • • Purpose of QA
  • • Responsibility of Quality Function
  • • Application of Permission
  • • Approval of Clinical Trial
  • • Medical Devices

Safety Reporting

  • • Adverse Event Reporting
  • • Recording of Event
  • • Medical Management of Adverse Events
  • • Handling Death
  • • Unblinding of Drug
  • • Clinical Safety and Pharmacovigilance

Privacy and Confidentiality

  • • Privacy and Confidentiality
  • • HIPPA
  • • Informed Consent Privecy
  • • IRB's Role in Protecting Privacy
  • • Data Protection

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.


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.


Career in Regulatory Affairs:

Regulatory Affairs carries out new research studies on human health, sicknesses and healthcare. Due to the exponential growth of the industry, there are several career opportunities in the Regulatory Affairs industry. Once students finish their Regulatory Affairs training programs, one can find lucrative job profiles in the industry. They are:


Safety Reporting

  • • Regulatory Affairs Associate(CRA)
  • • Regulatory Affairs Coordinator(CRC)
  • • Regulatory Affairs Investigator(CRI)
  • • Business Development Manager
  • • Regulatory Affairs Manager

Privacy and Confidentiality

  • • Medical Writer
  • • Data Manager
  • • Clinical Trial Auditor
  • • Project Manager
  • • Clinical Trial Writer

Sectors Where Candidates can find opportunities:

Candidates who have completed Regulatory Affairs Courses will be placed in the following sectors:


  • • Biotechnology Company
  • • Clinical Data Management Companies
  • • Pharmacovigilance Centers
  • • Pharmaceutical Companies
  • • IT Companies in Healthcare
  • • Central Laboratories
  • • Clinical CRO(Contract Research Organization)
  • • Data Management CROs(Contract Research Organization)
  • • Packaging Labeling and Contract Manufactures

Companies and Clients for Regulatory Affairs:


  • • Sciformix
  • • TCS
  • • Cognizant
  • • Springer Nature
  • • Cotivity
  • • Lupin
  • • Docplexus
  • • 3Gen Consultancy
  • • Augustus
  • • Accutest
  • • Iqvia
  • • Access Healthcare
  • • Emcure Pharmaceuticals

What is Regulatory Affairs?

Regulatory Affairs is a branch of healthcare sciences. It refers to all kind of research carried out on healthy or sick individuals. Also, it focuses on getting more information of deadly diseases. Moreover, the industry finds new treatment regimens for these illnesses. Furthermore, it also aims to find new cures for illnesses such as cancer and diabetes. With new drugs and devices, professionals will be able to improve the health of patients.

Novel research studies are structured and comprise of a precise study protocol .They are carried out in certain conditions. Firstly, they must aim to increase medical knowledge. Secondly, they must be carried out by qualified and trained Regulatory Affairs professionals. These professionals take all essential measures to protect volunteers who lend themselves to research. Later, they get the approvals of the regulatory bodies and take all the necessary legal and ethical steps. Therefore Regulatory Affairs field has a lot of growth potential for healthcare professionals.


Scope of Regulatory Affairs:

At present, India is the global hub of clinical trials. Owing to this, many MNCS are setting up their research centers. This is because clinical trials are the main part of Regulatory Affairs. Regulatory Affairs determines the safety and efficacy of medicines, devices and treatment regimen. This is usually done before their availability to the general public. Hence, there is a massive requirement for trained Regulatory Affairs professional in India and worldwide. For instance, a career in Regulatory Affairs provides excellent job opportunities in USA, Europe, Singapore and India. There are more than 2.5 Lakh opportunities worldwide in Regulatory Affairs. Furthermore, the global clinical trials market size is expected to reach USD 68.9 billion by 2026. It is projected to expand at a CAGR of 5.7% during the forecast period. Therefore, there is a huge scope for Regulatory Affairs in the coming years.


Career in Regulatory Affairs:

Regulatory Affairs focuses on new research studies about human health, sicknesses and healthcare. Hence, there are numerous career opportunities in the Regulatory Affairs industry. This is due to the exponential growth of the industry. Therefore, one can find several lucrative job profiles in the industry. They are:


  • • Regulatory Affairs Associate(CRA)
  • • Regulatory Affairs Investigator(CRI)
  • • Business Development Manager
  • • Regulatory Affairs Manager
  • • Medical Writer
  • • Data Manager
  • • Clinical Trial Auditor
  • • Project Manager
  • • Clinical Trial Writer

Sectors Where Candidates Can find Opportunities:

Candidates who have completed Regulatory Affairs Courses will be place in the following sectors:


  • • Biotechnology Company
  • • Clinical Data Management Companies
  • • Pharmacovigilance Centers
  • • Pharmaceutical Companies
  • • IT Companies in Healthcare
  • • Central Laboratories
  • • Clinical CRO(Contract Research Organization)
  • • Data Management CROs(Contract Research Organization)
  • • Packaging Labeling and Contract Manufactures

Companies and Clients for Regulatory Affairs:


  • • Sciformix
  • • TCS
  • • Cognizant
  • • Springer Nature
  • • Cotivity
  • • Lupin
  • • Docplexus
  • • 3 Gen Consultancy
  • • Augustus
  • • Accutest
  • • Iqvia
  • • Access Healthcare
  • • Emcure Pharmaceuticals

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