Comprehensive program on drug regulatory affairs, IPR, and patents for careers in pharmaceutical and healthcare sectors.
Certification :
Life Sciences Sector Skill Development Council
Duration :
6 Months
Delivery Mode :
eLearning - Live Sessions
Examination :
Online MCQ / Descriptive / Project
In Association With
An innovative clinical research training institute providing a wide range of clinical research training programmes.
Review all the details and discover more about what the course has to offer.
Introduction
This course on patents and patent drafting is designed to provide a general overview of intellectual property and to suggest useful practices for the handling of patent issues in the corporate setting. This course comprises of three modules addressing various processes involved in patent drafting.
View BrochureAbout Cliniminds
Established in 2004, trained over 11,000+ health & life sciences professionals in India, US, Canada, Australia, Europe, Middle East, Asia and Africa using Live eLearning platforms.
Cliniminds is an innovative skilling & training institute providing a wide range of life sciences and pharma sector training solutions in the field of clinical research, pharmacovigilance, clinical data management, drug regulatory affairs, pharmaceutical and healthcare business analytics, medical writing, biostatistics, clinical statistical analysis and programming and other programs to the graduates and post graduates, pharmaceutical & medical devices companies, CROs and healthcare companies worldwide.
Free Add on
Post Graduate Diploma in Pharmacovigilance
* The Free Add-On Program is available only for early registrations
Modules - 1 Drug Regulatory Affairs
- 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
Modules - 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
Study Mode
eLearning - Live Sessions
Duration
6 Months
Certificate
Life Sciences Sector Skill Development Council
Faculty
Fulltime Cliniminds Faculty & Visiting Experts from the Industry
Methodology
Live eLearning Sessions, eBooks, Audio Video Recordings and other content using Cliniminds Learning Management System.
Examination
Online MCQ / Descriptive / Project
Study Material
Access to Cliniminds Learning Management System 24x7 – Recordings, PPT, Notes, Modules, eBooks.
Placements
Extensive Placement Support. Pre Placement Training, Pitching CVs with Recruiters and assistance in arranging Interviews with the companies.
Eligibility
B.Pharmacy, M.Pharmacy, Pharm.D, Nursing, BSC, MSC, B.Tech Biotech, M.Tech Biotech, BDS, MDS, BHMS, BAMS, BPT, MBBS, all professionals working with Pharmaceutical companies, CROs and Life Sciences Consulting Firms
Entry-Level Positions:
- Regulatory Affairs Associate/Coordinator (Responsibilities: Assisting with regulatory submissions, maintaining regulatory files, ensuring compliance with regulations).
- Regulatory Affairs Specialist (Responsibilities: Preparing and submitting regulatory documents, interacting with regulatory agencies, supporting product development teams).
Mid-Level Positions:
- Senior Regulatory Affairs Specialist (Responsibilities: Leading regulatory submissions, developing regulatory strategies, mentoring junior staff).
- Regulatory Affairs Manager (Responsibilities: Managing regulatory projects, coordinating with cross-functional teams, overseeing regulatory compliance).
Senior-Level Positions:
- Regulatory Affairs Director (Responsibilities: Directing regulatory activities, formulating regulatory strategies, ensuring regulatory compliance across the organization).
- Senior Director/VP of Regulatory Affairs (Responsibilities: Overseeing all regulatory affairs activities, setting strategic direction, liaising with top regulatory bodies).
Specialized/Executive Positions:
- Chief Regulatory Officer (Responsibilities: Providing executive leadership in regulatory affairs, shaping regulatory policies, representing the organization at the highest levels.
- Consultant/Advisor in Regulatory Affairs (Responsibilities: Offering expert advice on regulatory strategies, helping organizations navigate complex regulatory landscapes).
Key Recruiters
Pfizer, Johnson & Johnson, Novartis, Roche, Merck, Sanofi, GlaxoSmithKline (GSK), AstraZeneca, Eli Lilly, Abbott, Bayer, Bristol-Myers Squibb, Amgen, Takeda, Boehringer Ingelheim, Teva Pharmaceuticals, Genentech, Novo Nordisk, Allergan, Biogen, Dr. Reddy's Laboratories, Cipla, Sun Pharmaceutical Industries, Biocon, Glenmark Pharmaceuticals, Lupin, Wockhardt, Cadila Healthcare (Zydus Cadila), Torrent Pharmaceuticals, Aurobindo Pharma, Alkem Laboratories, Jubilant Life Sciences, Piramal Enterprises, Natco Pharma, Intas Pharmaceuticals, Hetero Drugs, Alembic Pharmaceuticals, Strides Pharma Science, Freyr, IQVIA, PAREXEL, Covance, ICON plc, Syneos Health, Charles River Laboratories, Medpace, PRA Health Sciences, Pharmalex, Kinapse
Course Calender
Please contact counsellor for upcoming batch details 91 812 910 0876 / 1800 1023 566 (Toll Free)
Discover how we’ve made a difference in our students' journeys.
My name is Emmanuvel C V. I had done my post graduate diploma in Pharmacovigilance from MWT Global Academy, Kochi. They had arranged an interview for me at Cliantha Research in Ahmedabad. I attended the interview and was placed as Pharmacovigilance Assistant. I thank everyone who supported and helped me to achieve my career goals. Thank you MWT Global Academy!
Emmanuvel C V
Advanced Post Graduate Diploma in Clinical Research & Pharmacovigilance
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Kochi
Kottayam
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Whether you have questions, need assistance, or require specific information, our team is here to help. Find the right person to guide you quickly and efficiently, ensuring you get the support you need without delay.
Jidhin Joseph
Marketing Head
- jidhin@mwtacademy.in
- +91 8129100876
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MWT Academy, Bhattathiripad Road, Opp. Elamkulam Kavalakkal Temple, Off. Kaloor - Kadavanthra Road, Ernakulam.
