Post Graduate Diploma in Regulatory Affairs, IPR & Patents

Post Graduate Diploma in Regulatory Affairs, IPR & Patents

Regulatory professionals are the primary communication link between the company and global regulatory

agencies such as USFDA (United States Food and Drug Administration), European Union of Drug

Regulatory Affairs (EUDRA) and Drug Controller General of India (DCGI) and several other regulators globally.

The pharmaceutical, biotechnology and medical device research and development industries are amongst the highest regulated industries globally. As pharmaceutical sector is growing rapidly, there is a need of

regulatory affairs professionals to cater the current needs of industries for the global competition.

Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory

agencies. Pharmaceutical Industry, being one of the highly regulated industries, is in immense need of

people than ever before who are capable of handling issues related to regulatory affairs in a comprehensive manner.

In recent years we have been frequently hearing about the Intellectual Property Rights or IPR, in short.

The idea of ownership has given rise to the concept of property. Till recently, the term property was

always thought of in relation to some tangible assets, whose ownership could be established easily. In the new age of knowledge based society, the idea of having ownership rights in the intellectual creations has acquired strength and urgency. With globalization, India also has had to gear up for a paradigm shift from knowledge sharing society to knowledge owning society.

This course 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 four modules addressing various processes involved in patent drafting.

Full Time - Classroom - 6 Months - Project Work & Dual certification

Weekend - Classroom - 6 Months (Saturday & Sunday)

Eligibility          :         MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharms, Graduate/Post

Graduate Degree in Life Sciences, Mathematics, Pharmacology, Pharmacy,

Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and Hospitals.

M et ho dol o gy :             Classroom, Webinars & Online Learning System

Examination         :        Classroom, Group Discussion, Viva

C e r t if ic a t e            :        Certificate would be awarded upon successful completion of the

program.

J o b A s s is t a n c e :        Extensive Placement support would be provided to the successful candidates.

Fee Payment      :        ---

Program Details:         The program would cover:

Semester 1

I ntr oduc t ion to Re gul a t or yAf f a ir s

Pha r m a Re gul a t i ons Pr a c t i c e s a nd

Pr oc e dur e

GlobalPharmaceuticalIndustryScenari

Indian Pharmaceutical Industry Global Regulatory Environment

Regulations Governing Clinical Trials and

Ne w Dr ugs

Sc he dul e Y

Re gul a t or yI ns pe c t i ons i n Cl i ni c a l

Re s e a r c h ( FD A, EMEA, U Ka n d In dia n )

Fut ur e of Re gul a t or y C o m pl i a nc e

Or pha n Dr ugs

Toxicology-Primar ypharmacpology,

secondary pharmacology, safety

pharmacology, Single dose toxicity, repeat

dose toxicity, genotoxicity,

carcinogenecity, reproductive and

developmenttoxicity,localtolerance

Semester 2

Dos s i e r St r uc t ur e : Type of dos s i e r s , ke y

items and structure of dossier, Regional

differences

Common Technical Documents: Define

CTD,Str uctureofModule,disc ussionof

eachmodule,Datarequiredforsubmission

Regulatory procedure : USFDA -- Para III

filing, Para IV filing, EU -- MRP and DCP

procedure

Legal basis of submission: US -- 505

(b)(1), b(2) and (j) application; EU -- 10.1

and10.3

Data&Marketexclusivityprocedure:

generic products and orpha n drugs

I mpo r ta n d Exp o r to f Dr u gs

GoodManufacturingPractice

Quality Assurance and Regulations

Gl oba l Dr ug P ol i c i e s

RegulationinPharmaceuticalDevices

TRI P Ps a n d Ph a r ma I n d us t r y

Pha r m a c ovi gi l a nc e ( I nt r od uc t i on, gl oba l

reporting requirements)

Semester 3

IPR & Patents

IntroductiontoPatentRegime

I ntr oduc t ion to Pa t e nt s

Trademarks

Copyr i ght

Industrial designs

Tr ade Secrets

Geographical indications

Types of Patent

Patentability criteria

Patentablesubjectmatter/NonPatentable

subject matter

Ana to myo f Pa te n t

Te r m of a Pa t e nt

Expir yc a lc ula tion of pa t en ts .

Inventor ship

Dut y of Di s c l os ur e

Timelines

Type s of Se a r c he s

Va r i ous Se a r c h En gi ne s

Pe r f o r mi n g a Se a r c h ( Du m my St r a t e g y) &

Adva nt a ge s of pa t e nt s e a r c h

International Patent classification

Specification and Description

Writtendescription, EnablementandBest

moderequirement

Claims

Course Objectives:

Learn the skills, knowledge and competencies of a candidate for the Drug Regulatory and IPR jobs.

Become more familiar with roles/jobs as part of Drug Regulatory & Patents

Team

Basic concepts, importance of Regulatory Guidelines and Patents

Learn the skills, knowledge and competencies of a candidate for the Clinical

Research and Regulatory jobs

Become more familiar with roles/jobs as part of the study team.

Concepts, importance of Regulatory Guidelines and Patents