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
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)
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
