Lsssdc
Ncvet

Government of India LSSSDC - Live eLearning PG Diploma in Drug Regulatory Affairs, IPR & Patents

Government of India LSSSDC
Live eLearning PG Diploma in
Drug Regulatory Affairs, IPR & Patents
Recent Placements
Contact : +91-9560102589

Contact : +91-9560102589

PG Diploma in Drug Regulatory Affairs, IPR & Patents
BATCH COMMENCEMENT
Weekend - 6 Months Live eLearning
Classes Starting - Saturday, 30th December 2023
  • Live eLearning Sessions, Job Role Specific Training.
  • Hands on eCTD Software Training
  • 24x7 Online access to Learning Management System – Presentations, Notes, Modules, Session Recordings
9500+ Cliniminds Alumni
PG Diploma in Drug Regulatory Affairs, IPR & Patents
BATCH COMMENCEMENT
Weekend - 6 Months Live eLearning
Classes Starting - Saturday, 30th December 2023
  • Live eLearning Sessions, Job Role Specific Training.
  • Hands on eCTD Software Training
  • 24x7 Online access to Learning Management System – Presentations, Notes, Modules, Session Recordings
9500+ Cliniminds Alumni

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, NCVET, Ministry of Skill Development & Entrepreneurship, Government of India.
  • 2
    Advanced PG Diploma, Cliniminds - Program Accredited by Accreditation Council for Clinical Research Education, USA.

Certifications

  • 1
    Life Sciences Sector Skill Development Council, NCVET, Ministry of Skill Development & Entrepreneurship, Government of India.
  • 2
    Advanced PG Diploma, Cliniminds - Program Accredited by Accreditation Council for Clinical Research Education, USA.
Cliniminds is listed on LSSSDC

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

  • Introduction to Patent Regime
  • Introduction to Patents
  • Trademarks
  • Copyright
  • Industrial designs
  • Trade Secrets
  • Geographical indications
  • Types of Patent
  • Patentability criteria
  • Patentable subject matter/Non Patentable subject matter
  • Anatomy of Patent
  • Term of a Patent Expiry calculation of patents.
  • Inventor ship

Module 3

  • Duty of Disclosure
  • Timelines
  • Types of Searches
  • Various Search Engines
  • Performing a Search (Dummy Strategy) & Advantages of patent search
  • International Patent classification Patent
  • Introduction to patent drafting
  • Specification and Description
  • Written description, Enablement and Best mode requirement
  • 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), National Council for Vocational Education and Training (NCVET), under the Ministry of Skill Development & Entrepreneurship, Government of India.

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, Government of India 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.