Advance Program in
Drug Regulatory Affairs (APDRA)
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Description
Program Highlights
Drug Development Process
Indian Regulations - Indian Scenario - D
Indian Regulations - All Indian Schedules
eCTD submissions
CTD guidance for Industry - CDSCO
US FDA guidelines on eCTD Submissions
Various schedules
Eligibility for Advance Program in Clinical Research and Management
B.Pharm, M.Pharm and Pharm.D
B.Sc. M.Sc and Ph.D (Biotechnology, Microbiology, Biochemistry and Nursing etc)
B.E., B.Tech. M.Tech (Biotech/ Biomedical Engineering)
BPT, MPT, BDS, BAMS, BHMS and MBBS etc
Course Syllabus
Introduction to Regulatory Affairs
Drug Development Process
Regulatory Submissions and Strategies
Pharmaceutical Quality Assurance and GMP Compliance
Regulatory Strategies for Different Types of Products
Regulatory Compliance and Post-Market Surveillance
Regulatory Affairs in Specific Regions
Emerging Trends and Future Developments in Regulatory Affairs
Note: This syllabus is a broad outline of the Program, Modules will be delivered as per the class requirements and audience qualification. Program modules can be changed as per the requirements.
Contact us
Call & Enroll over the phone with one of our representatives
Ring at : +91 888.690.4030
222,7510 people are learning on Clini India today…
Key Features
Learn From Corporate Experts / Faculty
Case Study Based Learning
Life Time Learning Management System Access
Detailed Curriculum
Mock Interviews
Flexible Batch Timings
Work on Assignments & Case Studies
Learning Management System (LMS)
Through our robust Learning Management System, students gain 24/7 access to a treasure trove of resources, including pre recorded video lecture materials, quizzes, and collaborative forums. This virtual platform facilitates seamless communication with instructors, fostering a dynamic exchange of ideas. The LMS also supports online exams via https://cliniindia.com/exam/ensuring personalized learning journeys. With user-friendly interfaces and multimedia integration, our LMS transforms education into an engaging and accessible adventure, providing the tools necessary for students to thrive in the ever-evolving landscape of clinical research and management.
Our APCRM Course Fees
Admission Process
Candidate can easily apply through our official website. Our admission officers will review your application and
contact you for further process.
01
Raise an enquiry via website
02
You will be connected to our program advisor
03
Select a Program and submit application form and pay registration fee
04
Application review and acknowledgement
05
Enrolment and Confirmation
Placement Process
Our institute’s placement process guides students toward their ideal career path, offering insights and resources to enhance employability. While we don’t guarantee jobs or interviews, we empower students with resume refinement, interview preparation, and networking skills. Our comprehensive career guidance sessions provide valuable industry insights, helping students navigate diverse opportunities. The focus is on skill development and self-marketing, ensuring graduates are well-equipped for the competitive job market. By fostering a proactive approach to career planning, we aim to maximize the potential for success and fulfillment in their chosen fields.
Our Placements
Career Triumphs: APCRM Graduates Shine Bright in Corporate Placements
Career Opportunities
Pharma Regulatory Affairs professionals play a crucial role in ensuring compliance with regulatory requirements, navigating complex approval processes, and contributing to the safe and effective marketing of pharmaceutical products. Here are some career opportunities and job profiles in Pharma Regulatory Affairs:
Regulatory Affairs Specialist/Associate:
- Prepare and submit regulatory documents for product approvals.
- Interact with regulatory agencies to address queries and provide necessary information.
- Ensure compliance with local and international regulations.
Regulatory Affairs Manager:
- Lead and manage regulatory affairs teams.
- Develop regulatory strategies for product development and approvals.
- Oversee the preparation and submission of regulatory documents.
Clinical Regulatory Affairs Manager:
- Focus on regulatory aspects related to clinical trials.
- Develop strategies for obtaining regulatory approvals for clinical trial protocols.
- Ensure compliance with Good Clinical Practice (GCP) standards.
Quality Assurance Specialist (Regulatory Compliance):
- Ensure manufacturing and quality processes comply with regulatory standards.
- Conduct internal audits to assess regulatory compliance.
- Collaborate with regulatory affairs teams to address compliance issues.
Regulatory Affairs Consultant:
- Provide specialized regulatory advice to pharmaceutical companies.
- Assist in regulatory strategy development and submissions.
- Offer expertise on specific regulatory challenges.
Regulatory Affairs Project Manager:
- Manage regulatory projects, ensuring timelines and milestones are met.
- Coordinate activities between regulatory affairs, clinical, and quality teams.
- Provide strategic direction for project regulatory activities.
Regulatory Affairs Specialist:
- Focus on regulatory aspects related to product manufacturing and quality.
- Ensure compliance with Good Manufacturing Practice (GMP) standards.
- Collaborate with manufacturing and quality assurance teams.
Pharmacovigilance Specialist:
- Monitor and report adverse events associated with pharmaceutical products.
- Ensure compliance with pharmacovigilance regulations.
- Develop and implement risk management plans.
Regulatory Affairs Analyst:
- Analyze regulatory requirements and assess their impact on product development.
- Provide recommendations for regulatory strategies based on analysis.
- Keep abreast of changes in regulatory landscape.
Regulatory Affairs Auditor:
- Conduct internal and external audits to assess regulatory compliance.
- Identify areas of improvement and recommend corrective actions.
- Ensure adherence to regulatory standards.
Regulatory Affairs Liaison:
- Serve as a liaison between the company and regulatory agencies.
- Facilitate communication and information exchange during regulatory interactions.
- Build and maintain relationships with regulatory authorities.
Salary and Career Growth
Program Outcomes
Need for Regulatory Affairs (RA) professionals is required in the Pharma Industry and essential qualities of RA professionals.
Basic understanding and terminologies related to Pharma Drug Regulatory Affairs (DRA).
Understand the role of a Regulatory Affairs Professional in Pharmaceutical industry
Major Agencies for Drug Regulations In Different Countries.
Common Technical Document (CTD), Modules, ACTD Vs ICH-CTD.
Drug Master File- Related Terms, benefits, Annual update, Database status, Requirements, Process, Types, etc.)
Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA etc.
Industry
The Top Sectors within the Clinical Research Industry
In the Pharma Regulatory Affairs industry, various stakeholders play crucial roles in ensuring compliance with regulations, facilitating drug development, and supporting the safe and effective marketing of pharmaceutical products. Key stakeholders in this industry include:
Pharmaceutical Companies
Develop and manufacture pharmaceutical products.
Responsible for regulatory compliance and submissions for product approvals.
Regulatory Agencies
Government entities overseeing drug approvals and regulatory compliance.
Examples include the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, and others.
Clinical Research Organizations (CROs)
Organizations providing support for clinical trials, including regulatory compliance, protocol development, and monitoring.
Contract Manufacturing Organizations (CMOs)
Companies involved in the manufacturing of pharmaceutical products under contract for other pharmaceutical companies.
Legal and Compliance Teams
Legal professionals ensuring that pharmaceutical companies comply with all applicable laws and regulations.
Ethics Committees and Institutional Review Boards (IRBs)
Review and approve clinical trial protocols, ensuring ethical conduct and compliance with regulations.
Trade Associations
Industry groups that advocate for the interests of pharmaceutical companies and provide resources for regulatory compliance.
Suppliers and Service Providers
Companies supplying materials, equipment, and services to pharmaceutical companies, ensuring compliance with quality standards.
Insurance Companies
Entities responsible for covering the costs of pharmaceutical products and ensuring compliance with reimbursement regulations.
International Organizations
Organizations such as the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that contribute to global regulatory harmonization.
Testimonials
What Our Students Have To Say
Listen to the stories of our students, as they articulate the profound influence of our educational environment. Their testimonials encapsulate the enriching experiences and valuable insights gained throughout their educational endeavors.
Doing the CR program from CLINI INDIA was a life-changing experience for me. The practical skills backed by academic knowledge have given me the confidence to pursue a career in any domain in the Clinical Research Industry.
Manish
The quality of lecturers surpassed my expectations, and they represented a great blend of all modules in Clinical Research. I found the program is a milestone in my professional career.
Saba
My Training at CLINI INDIA was full of learning with the utmost knowledge. It made many positive frameworks in my attitude, Technical skills, work style, personality and behavior to shape best out of this Competitive world or Clinical Research. Thanks to Team CLINI INDIA for career support.
Anurag Shukla
Enrolling in CLINI INDIA was a valuable investment for me. In addition to broadening my perspective in the Clinical Research field, it has helped me to grow both professionally and personally. Thanks to CLINI INDIA, I am working with World’s Leading CRO in Bangalore
Prasanta Kumar Gouda
CLINI INDIA is a great institution. The staff and instructors are always helpful and are looking out for you. I have got placement before my course Completed. The atmosphere is great. I have made friends that I will have forever.
Golak Bihari Praharaj
Hands-On Training in Pharmacovigilance Database
Practical training in medical coding is Important as it bridges the gap between theory and real-world application. Case study bases learning equips aspiring coders with hands-on experience crucial for accuracy and efficiency. It enhances proficiency in code assignment, ensures compliance with evolving guidelines, and fosters a deep understanding of the intricacies within the healthcare landscape. Practical training cultivates problem-solving skills, critical thinking, and adaptability, preparing coders for the dynamic challenges they’ll face in the industry. This experiential learning not only solidifies theoretical knowledge but also instills confidence, making individuals better-prepared and more effective contributors to the essential field of medical coding.
Why Choose APCRM?
Comprehensive Curriculum
Covering key aspects of clinical research, our program ensures you are well-versed in every facet, setting you on a path for success.
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Industry-Driven
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Flexible Online Learning
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Embark on a transformative journey with APCRM, where we nurture the next generation of clinical research leaders.Join us in shaping the future of healthcare through excellence in research and management.
Here Is The Most Frequently Asked Questions
What is Clinical Research, and why is it important for healthcare?
How can I start a career in Clinical Research as a fresh graduate?
What skills are essential for a career in Clinical Research?
Are there specific educational requirements for entering the field of Clinical Research?
- B.Pharm, M.Pharm and Pharm.D
- B.Sc. M.Sc and Ph.D (Biotechnology, Microbiology, Biochemistry and Nursing etc)
- B.E., B.Tech. M.Tech (Biotech/ Biomedical Engineering)
- BPT, MPT, BDS, BAMS, BHMS and MBBS etc
What types of job roles are available in Clinical Research for entry-level professionals?
How important is networking in building a career in Clinical Research?
What are the key challenges faced by professionals in Clinical Research?
Can I get 100% Placement Guarantee after completion of the program?
What role does ethical considerations play in Clinical Research, and how are they addressed?
What are the potential career advancement opportunities in Clinical Research?
DISCLAIMER: Placement Services
We encourage our students to actively participate in career development activities, utilize the resources provided by the institute, and take advantage of networking opportunities to enhance their employability. [Institute Name] may facilitate career-related workshops, seminars, or connect students with industry professionals, but this is solely for educational and informational purposes.
It is essential for students to exercise due diligence, proactively seek employment opportunities, and engage with potential employers independently. Any claims or representations suggesting guaranteed placements by external entities or individuals on behalf of CLINI INDIA are not endorsed by the institute.
