Certified Drug Regulatory Affairs Professional

Company Connect Consultancy has brought an opportunity to become a Certified Drug Regulatory Affairs Professional for those who understand the basic stages of the industrial production life cycle and their regulatory requirements. The certification would impart among the candidates the ability to examine specific regulations that governs the Pharma industry in USA, Europe, UK, Canada, Japan, India etc. The curriculum of the certification is designed as a comparative analysis of Pharma regulatory systems of different nations integrated with concrete management tools of the supply chain like, Certification schemes, Regulatory compliance with government guidelines, product approval procedures etc.

 

To obtain the certification, candidate must clear the qualifying exam for which proper training materials will be provided by the institute. No extra charges will be applied for this material.

 

Our training for the preparation of this certification is aimed at improving the conceptual knowledge of the participant towards formation of efficient public policies, compliance with regulatory guidelines, the regulatory strategies of companies in the food industry, and resolving any dilemmas that a working professional may face at respective workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study resources have been carefully designed to introduce the participant to various aspects and basics of industrial applications, its need, and benefits in assuring quality production.

The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified Drug Regulatory Affairs Professional in the domain. An advanced training having rigorous case studies based methodology will be imparted to all participants to prepare for the Certifying Examination. 

Study Modules

  • Regulatory Authorities around the world

  • Various stages in Drug development

  • Introduction to the GMP concept

  • Methodological regulatory filing around the world

  • Common Technical Document Filing. eCTD submission process

  • Intellectual Property Rights in Pharma Industry

  • Quality Assurance and Drug Regulations, ICH and WHO guidelines

  • Guidelines for Import and Export of Pharma products

  • Audits by the Government and Regulatory bodies

  • Breach reports and Compliance guidelines

  • Drug Registration in African Countries.

  • Drug Registration in Gulf (GCC) Countries.

  • AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)

  • Industry specific case studies

Eligibility

Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

The candidate is expected to complete the course in 2 months.

Registration

The registration will be carried out by contacting on Company Connect Consultancy. How to Apply

Programme Deliverables

A comprehensive study material for all the modules in Soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance.

  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.

  • Online classes for all the modules will be conducted on the weekdays or Weekend (as per batch you choose). Moreover, a doubt clearing session will also be scheduled before the examination.

  • All the efforts are made by faculty members to make the entire programme modules easily understandable.

  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.

  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.

  • All learning and training delivery initiatives shall be conducted in English.

Certification and Membership Fees

Contact on +91-9691633901 or Info@companysconnects.com for details of fees structure 

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as GCP Professional by Company Connect.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. 

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like IQVIA, Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc.