Lsssdc
Skill
Drug Regulatory Affairs, IPR & Patents
Drug Regulatory Affairs, IPR & Patents
Contact : +91-93104 85979 / +91-95601 02589 / +91-95601 02587

Contact : +91-93104 85979 / +91-95601 02589 / +91-95601 02587

Free Add on Diploma in Pharmacovigilance
Recent Placements

Drug Regulatory Affairs, IPR & Patents
Life Sciences Sector Skill
Development Council Program
Weekend - 6 Months Live eLearning
BATCH COMMENCEMENT
Classes Starting - Thursday, 18th August 2024
  • Live eLearning Sessions, Job Role Specific Training.
  • Hands on eCTD Software Training
  • 24x7 Online access to Learning Management System – Presentations, Notes, Modules, Session Recordings
10000+ Cliniminds Alumni
Life Sciences Sector Skill Development Council (LSSSDC), a Sector Skill Council, set up by National Skill Development Corporation (NSDC) along with Industry Representatives. LSSSDC is an approved & recognized Vocational Education Awarding Body by National Council of Vocational Education and Training (NCVET), and working under aegis of Ministry of Skill Development & Entrepreneurship (MSDE) for the Skill development initiatives in Life Sciences Sector which includes Pharmaceutical (including AYUSH, Cosmetics, Vet-Drugs, Nutraceutical and CRAMS), Biotechnology (including Biologics and Allied Biotech), Medical Device (inclusive of Implants, Diagnostic Imaging & In-Vitro Diagnostics) and Research & Development Services Industry across the country.
Drug Regulatory Affairs, IPR & Patents
Life Sciences Sector Skill
Development Council Program
Weekend - 6 Months Live eLearning
BATCH COMMENCEMENT
Classes Starting - Thursday, 18th August 2024
10000+ Cliniminds Alumni
Life Sciences Sector Skill Development Council (LSSSDC), a Sector Skill Council, set up by National Skill Development Corporation (NSDC) along with Industry Representatives. LSSSDC is an approved & recognized Vocational Education Awarding Body by National Council of Vocational Education and Training (NCVET), and working under aegis of Ministry of Skill Development & Entrepreneurship (MSDE) for the Skill development initiatives in Life Sciences Sector which includes Pharmaceutical (including AYUSH, Cosmetics, Vet-Drugs, Nutraceutical and CRAMS), Biotechnology (including Biologics and Allied Biotech), Medical Device (inclusive of Implants, Diagnostic Imaging & In-Vitro Diagnostics) and Research & Development Services Industry across the country.

Program Inclusions

  • Live eLearning Sessions, Job Role Specific Training – Saturday & Sunday
  • Hands on eCTD Software Training
  • 24x7 Online access to Learning Management System – Presentations, Notes, Modules, Session Recordings

Job Placements - Dedicated Placement Department

  • Assistance in Setting up Job Interviews - 360° Placement Support - Pitching CVs to Recruiters
  • Pre Placement Training - CV preparation, Mock Interviews, English Communication, and other job placements seeking skills.
Download Course Brochure

Certifications

  • 1
    Life Sciences Sector Skill Development Council.
  • 2
    Advanced PG Diploma, Cliniminds - Program Accredited by Accreditation Council for Clinical Research Education, USA.
  • 3
    Internship Certification – www.thinki.in

Certifications

  • 1
    Life Sciences Sector Skill Development Council.
  • 2
    Advanced PG Diploma, Cliniminds - Program Accredited by Accreditation Council for Clinical Research Education, USA.
  • 3
    Internship Certification – www.thinki.in

Module 1

  • Drug Development Process & Introduction to Clinical Research
  • Introduction to Regulatory Affairs, Terms & Terminologies & Abbreviations
  • Chemistry, Manufacturing & Controls (CMC)
  • Drug Master File
  • Regulatory, Filing System for DMF in Different Countries
  • ICH – Introduction, Objectives & Guidelines
  • CTD Introduction - Module 1 to 5
  • Regulatory Filing Systems in Europe
  • Regulatory Filing Systems in US
  • Registration Procedures in Rest of the World
  • Validations
  • Audits & Compliances
  • Regulatory Operations
  • Pre Publishing
  • Publishing
  • Final Submission via Gateways
  • Practical Approach towards Overall Dossier Preparation & Submission
  • Pharmacovigilance Regulations
  • Indian Pharmaceutical Regulations

Module 2

  • Essential Intellectual Property and Patent Management
    • Fundamentals of Intellectual Property (IP)
      • Introduction to the IP Regime: Patents, Trademarks, Copyrights, Industrial Designs, Trade Secrets, Geographical Indications
    • Patent Essentials
      • Understanding Patent Types and Patentability
      • Anatomy of a Patent: Subject Matter, Inventorship, Term, and Expiry
    • Patent Application Process
      • Disclosure Duties, Timelines, and Search Strategies
      • Drafting Patents: Specification, Description, and Claims
Cliniminds Awarded Institution with Excellent Training & Placements at Business World Top Education Brands Awards

Cliniminds has entered into the agreement with Life Sciences Sector Skill Development Council (LSSSDC) under the Ministry of Skill Development & Entrepreneurship.

Cliniminds – www.cliniminds.com – Established in 2004, offers life sciences sector job oriented, up skilling and professional training programs in the areas of clinical trials, pharmacovigilance, data management, business analytics, medical writing, regulatory affairs and other specialized areas. Cliniminds has an alumni of over 9500 professionals from India, US, Europe, Middle East, Africa and Latin America. Cliniminds programs are accredited and certified by Life Sciences Sector Skill Development Council, Ministry of Skill Development & Entrepreneurship and Accreditation Council for Clinical Research Education, USA.

Cliniminds Awarded Best Pharma Skilling Institute of India by PHD Chamber of Commerce and Industry

This program offers a Certificate Program in Drug Regulatory Affairs, IPR & Patent, in addition to the USA ACCRE Accredited Post Graduate Diploma provided by Cliniminds. The LSSSDC certification will enhances the value of your qualifications and also significantly boosts your prospects for successful job placements.

Cliniminds has seasoned senior industry experienced faculty, experienced placement team, robust IT platform, ERP/LMS, and business development teams. Cliniminds has strong international foot print has active students form 20+ countries, including developed markets like US and Europe. Cliniminds has recently singed the MoU with the leading Management & Science University, Malaysia to offer Cliniminds training program at their Malaysian campus. Cliniminds provides corporate training solutions to the leading corporates like Oracle, Birla Soft, Ultragenic, Bio Pharma, USA and many more.