Advance Regulatory Affairs Certification Course

Drug Regulatory Certification Course With Internship And Placements
Clin Infotech is one of India’s leading best Regualatory Affairs Training institute in India headquartered in Hyderabad. We also have a subdivision in Bangalore Pune and Mumbai India, providing quality education and experiential learning in Regulatory Affairs by imparting the Internship Program in Pharma Regulatory Affars Certification courses for the life science graduates and Post Graduates, we are keen to Expertise you with the additional skills with our practical Training methodology and preparing them for a rewarding career in the healthcare and pharmaceutical industry and make Job Ready with the updated Regulatory Affairs Interview Questions.

Regulatory Affairs Training and Internship

Learn With Live Projects

Clinical Research Internship @ ClinInfotech

Elevate Your Clinical Research Skills with our Intensive Training and Internship Program
Our Regulatory Affairs Training and Internship Program offers a comprehensive learning Work Experience for students interested in a career in Pharmaceutical industry.
Join our transformative Internship program and immerse yourself in dynamic learning with real-time Projects daily online classes, and internships. Our training methodology is confined to both theoretical and real-time industry. Enhance your resume and make meaningful connections. Earn course completion certificates to validate your expertise and boost your Employability and Open doors to exciting career opportunities in top Health Care Companies with Excellent Salary Packages.

The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.

The RA department plays an important role in giving advice to the project team on how best to interpret the rules. During the development process sound working relations with authorities are essential, e.g. to discuss such issues as divergence from guidelines, the clinical study programme, and formulation development.

What is a Regulatory Affairs?

Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.

What is the Scope of Regulatory Affairs?

Drug regulatory affairs are a diverse field with a lot of room for advancement. As stated in a National Geographic article, “There are more viruses than stars in the universe,” this demonstrates how little we know about the universe and the creatures that inhabit it. These viruses are the source of many deadly diseases that have been bestowed upon us, necessitating the development of a more robust and effective healthcare system.

The role of the regulatory professional

Regulatory professionals are responsible for:

• Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products
• Advising on legal and scientific restraints and requirements
• Collecting, collating and evaluating scientific data
• Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned
• Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole
• Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

Where do regulatory affairs professionals work?

Along with the promise of job security, pursuing a career in regulatory affairs affords you a great deal of flexibility in where you choose to work.
As of 2018, 73 percent of regulatory professionals work directly in a regulated industry, such as pharmaceuticals, medical devices, biotechnology, or food science. Just fewer than eight percent choose a consultative path, gaining employment at legal, research, or marketing firms. The remainders are employed by a mix of academic institutions, clinical research organizations, government agencies, hospitals, and healthcare organizations. With so many options, regulatory professionals can choose to work in organizations of any size, ranging from 10 to 10,000 employees.

Jobs in Regulatory Affairs

There is a wide variety of careers in the regulatory affairs field. Regulatory professionals carry titles such as:

• 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

Advanced Certified Program in Regulatory Affairs

Due to this predicament, a variety of clinical research organizations have recently emerged, including full-service CROs, early-phase CROs, SMOs, companies that provide highly specialized services like data management, clinical research consultancies, KPOs, and others. Because of this, there is now a greater need for qualified workers in the clinical research industry.
In-depth education in the specialist area of clinical research will be provided in this course. It offers thorough academic and practical instruction.

Benefits of our Regulatory Affairs Courses

The Regulatory Affairs Program at Clin Infotech 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.

Regulatory Affairs Course Content:

Download the Syllabus: Blink

Eligibility:

Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:

Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) and all professionals working with Pharmaceutical companies, CROs and Hospital.

Selection Procedure:

• To Maintain High Academic Standard, Clin Infotech Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:
• Personal Interview
• Screening And Selection Of Students

Why Clin Infotech for Regualtory Affairs course:

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Placement Preparation Program

Our HR team also provides the following upon successful completion of training:

It's time to comprehend and put standard trail management ideas into practice in order to build a solid methodology for the evaluation and boost the timely completion of crucial trials for the benefit of patients. To plan, produce, monitor, and complete all project duties, you must acquire specific skills and knowledge.
Through its comprehensive certification program, Clin Infotech offers thorough instruction in clinical research throughout the whole clinical trial process. With the help of this clinical trial management course, instructors will make sure that students have a procedural and administrative understanding of the clinical trial process as well as the capacity to advance their knowledge and abilities.
This curriculum will teach you the whole Regulatory responsibilities involved in Document Creation; Planning, Organizing, Monitoring, Recording, Analysis, and Reporting of Human Clinical Trials, as well as the most recent discoveries and specialties in e-Clinical Technology.

Enroll now!!

Take advantage of this opportunity to engage with cutting-edge industry technologies and learn how to apply them in the domain of Clinical Trial Management.

certification:

Certificate will be provided for this Course on successful completion of Assignments & Projects.
Certificate would be awarded at the end of the program by Clin Infotech. A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.

Our Placement Companies :

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Contact Us

For more information, please contact Clin Infotech at:
Email: careers@clininfotech.com
Phone: 8374457387