http://www.inclinition.com
Post Graduate Diploma in Advanced Pharmacy (PGDAP)
Regulatory Affairs (RA), Intellectual Property Rights (IPR), Quality Assurance (QA),
Quality Control (QC), Clinical Research (CR), Pharmacovigilance (PV), Scientific-Medical
Writing (SMW), Pharmaceutical Management (PM)
Distance Learning Course Brochure
InClinition
“Comprehensive Research Solutions”
Bridging gaps in industry and academia
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Pharmaceutical industry: India fact file
Pharmaceutical industry is also called as “sleeping giant”. This industry is world’s largest
industry in terms of revenues and investments. Its world’s recession proof sector and is highly
organized and regulated. Indian pharmaceutical industry is third largest pharmaceutical market
in terms of volume and fourteenth in terms of value. Currently, Indian pharma industry is
growing at rate of 15% compound annual growth rate. Different segments such as clinical
research, contract research, contract manufacturing and project management are having very
high demand now a day.
Why not current academic courses by universities?
Presently academic courses such as M Pharm, B Pharm, M Sc, B Sc are delivered by various
Indian universities. They are in demand and are required as mandatory qualification for jobs.
But these course are running on the basis of syllabus set by universities board of studies (BOS)
somewhere around 4-5 years back. As industrial environment is constantly changing with
emergence novel concepts, new techniques and technologies in market, current academic courses
fail to provide them as the syllabus revision takes a long process.
Considering this fact,
InClinition’s has come up with thought to train graduates as per changing industrial environment.
Our educational affairs team comprising of experts from industry as well as academia revise
syllabus according to changing industrial environment and based on student needs and
willingness to gain more knowledge.
Why this course?
The aim of this course is to impart industrial knowledge to students which serves to fill gaps in
current academic courses. This course will enable students of life sciences and pharmaceuticals
to understand industrial processes and techniques. Students of this course will be trained by
different industrial experts to provide them real time knowledge at par with industry. This is the
state of art course in India wherein all aspects of pharmaceutical industry will be covered.
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Why our course? Not others
Get trained by industrial experts from various domains of pharmaceutical industry
Pioneers in development of Advanced Course in Pharmaceuticals
We are only organisation in India providing bridging course in pharmaceuticals
Course is delivered in friendly and informal way of learning in small batches/groups.
This gives you plenty of opportunity to discuss individual issues, problems, and solutions
with trainers enabling you to build up valuable knowledge
Our courses are affordable and reasonably priced. No hidden costs incurred.
Confluence of experts’ solutions
With knowledge about global scenario and local expertise across different continents, we know
beat of market. Our strategies and education advices backed by the strongest evidence and
analytics help students to bring dreams into reality.
Our “R” approach i.e. right expertise, right product and right place helps us to remain focused
and to meet expectations of pharmaceutical companies.
Our expertise in
Pharmaceuticals
Cosmetics
Regulatory affairs
Biotech
Clinical Research
Foods and beverages
Healthcare
Market Research
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Career avenues after completion of PGDAP: Recipes for success
Are these recipes for success? No certainly not.
After completion of course you will be able to pursue career in domains such as production, QA,
Analytical development / QC, bioanalytical, supply chain management, logistics, finance control,
product management , marketing, techno commercial marketing, training, procurement, HR,
formulation development, regulatory affairs, clinical research, pharmacovigilance, medical
writing, data management, etc. and many more.
Eligibility
B. Pharmacy (Third and Final year students can also apply) and M. Pharmacy
B.Sc. Chemistry/Biotechnology/Life Sciences/Biochemistry/Microbiology (Final year
students can also apply)
M. Sc. Bioanalytical Sciences/ Microbiology/ Chemistry/ Biochemistry/Biotechnology
Candidates currently working in industry can also apply.
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Course modules Distance Mode
Module 1 Job essentials
How to deal with psychometric and aptitude tests
Job descriptions of pharma industry
How to target job- Job search overseas and India
How to make CV, Resume, Biodata and covering letter
Module 2 Regulatory affairs (RA)
Liaison with FDA
Common Technical document (CTD) and dossier preparation
Indian regulatory framework (CDSCO, IPC, DCGI, ICMR, GEAC)
MHRA, US FDA, EMA and EU Directives
Indian vs. WHO comparison
Therapeutic Goods Administration (TGA), Australia
Pharmaceutical and Medical Devices agency (PMDA), Japan
State food drug administration (SFDA), China
Herbal medicine regulations in India
Global regulations for medical devices
Drugs and cosmetics act and rules, 2013
BA/BE studies - regulations in India and US
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Module 3 Intellectual property rights (IPR)
Intellectual Properties rights
Patents (Indian, US, EU, WIPO patents)
Trademarks
Other related rights
Industrial designs
Geographical indications
Requirements for patent filing
Patent disputes case studies
Module 4 Quality control (QC)
Dissolution testing of pharmaceuticals with statistical modelling (software will be
provided to students for dissolution modelling)
Analytical method development and validation (Q2)
Interpretation of spectra of DSC, XRD, IR, etc
Impurities profiling Q3
Preparation of SOPs, COA, analytical development report (ADR), Finished product
specifications, (with reference to Q6)
Medicinal chemistry with focus on drug discovery, Computer aided drug design, In silico
techniques, API synthesis and HTS
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Module 5 Quality assurance (QA)
Concepts of Total Quality Management (TQM)
Quality audits, Vendor audit, Internal audits, FDA audits, facility inspections, etc
Quality of biotech product Q5A- Q5E
Pharmaceutical development Q8
Quality risk management Q9
Pharmaceutical quality management Q10
Module 6 Basics of Clinical research (CR)
Drug discovery and development, ICH E8, stake holders in clinical research
Preclinical and Toxicity testing of pharmaceuticals (ICH S guidelines)
Good Clinical Practice (difference of ICH, Indian GCP)
Clinical Data management E2A to E2F
Clinical trial design
Module 7 Pharmacovigilance (PV)
Drug safety monitoring, ADR timelines, guidelines, etc
Adverse drug reactions and dictionaries with medical coding
Benefit risk assessment
Signal detection
ADR case processing
Pharmacovigilance program of India
Pharmacovigilance for herbal drugs
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Module 8 Scientific, medical, regulatory and medico marketing writing and editing (SMW)
Referencing software
Article writing basics
Manuscript writing
Selecting target journal
Reviewing and editing of manuscript
Medical and regulatory writing
Medico marketing writing
Module 9 Pharmaceutics and formulations
1. Formulation Development of pharmaceuticals, NDDS, Generics, etc
2. Process and plant design of pharmaceuticals including HPAPI facilities
3. Scale up and post approval changes (SUPAC)
4. Preparation of BMR, COA, FDR, MFR, change control, deviation control and other
documents
Module 10 Pharmaceutical Marketing (PM)
1. Pharma marketing basics
2. Market research
3. Project management
All course modules are mandatory. Industry experts will deliver the course modules.
Presentations of lectures in classroom training course will be sent to students of distance learning
course by email and our virtual learning platform. InClinition reserves right to alter contents and
duration of module at any point of time. Student will be provided setup of software relevant to
above modules via Dropbox or any other virtual drive application. For distance learning students,
one contact session (for module) of three hours will be organised using Skype or Google hangout
so that doubts of students will be cleared.
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Course Material
Course material will be delivered to student by email along with virtual drive application once
every month. Along with this, presentations of study material will be uploaded to Android
application. As we believe in Green Environment Culture we don’t send printed study material
to any of our candidates.
Examination
There will be no end of course examination. Each module has formative assignment based on
industrial setting which counts for the marks of that module. All submissions of modules and
project should be prepared using MS word programme and sent to our email address for
evaluation. After completion of modules, one small project related to area in which student wish
to pursue his/her career needs to be submitted. This area will be mentioned as specialisation in
your certificate of PGDAP. After sending project thesis document, viva voce of 100 marks will
be conducted preferably on Sunday.
Minimum 50% should be obtained per module, project and viva voce.
Passing criteria: Each module carries 100 marks.
Project in area of specialisation: 100 Marks
Viva voce after project: 100 marks
Total course duration: 1 year
Certification
Certificate will be issued to students after successful completion of course. As we believe
excellence in our self, our course is not affiliated to any university or granting body. Certificate
and mark list will be sent to student via courier to his/her registered communication address.
Number of seats
There will be only 20 (Sixteen) seats for one year i.e. batch of course.
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Benefits along with course
InClinition’s exclusive Android Application – Only Pharma institute in India offering
Android application.
Virtual classroom / learning environment – so that discussion can be initiated amongst
course student fellows
Examination online - online examination or assignments of the course
e-Newsletter – Receive the fortnightly electronic information resource providing
information on global activities, networks, products and services.
Experts group membership – Join experts group discussion forum to get your questions
answered
Scientific meetings updates – Get update on workshops and meetings directly on your
mailbox.
Coverage of regulatory and government policies- Get updates on these via electronic
information resource
Course Fees
12,000 INR (Twelve thousand INR only) – For Indian nationals
15,000 INR (Fifteen thousand INR only) – For SAARC countries
450 US Dollar only – For other countries of world
Placements
As students of this course are participating in distance mode, we are providing only placement
assistance to them. We cannot guarantee placements to them. We are committed to provide latest
knowledge of software’s and systems in industry. But we can refer our student’s for placements
in industry.
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Advisory board and faculty
1. Amrit Karmarkar, ELS, Editor in Chief, Pharma Utility
2. Dr. Indrajeet Gonjari, Asst. Director, AICTE, New Delhi
3. Atul Shirgaonkar, Director and Owner, Insight Systems Inc. , Pune
4. Avinash Deodhar, Manager (Formulation), Bayer Pharmaceuticals, Thane
5. Sudhir Pandya, Manager- QA and R&D, NuLife Pharmaceuticals, Pune
6. Abhijit Bapat, Accounts Director, Mintel Ltd., Mumbai
7. Anil Bankar, Chief Coordination Officer & Researcher India Health Congress
2013, Constellation Communication & Events, Dubai and India.
8. Sagar Barve, Medical Writer, Cognizant Technology Solutions, Navi Mumbai
9. Adv. Naresh Singh, Ethics Committee Member, KEM Hospital, Pune
and many more
Knowledge Partners
Media Partners
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Contact Us:
InClinition
Call for admissions: +91-8898904115/ +91-9322189987
Email: info@inclinition.com
Website www.inclinition.com
Join us on Social Media
Linkedin: http://www.linkedin.com/company/inclinition
Facebook: http://www.facebook.com/InClinition
Twitter: http://twitter.com/InClinition
Address
13, Hari Preet, Pendsenagar Road no. 4,
Dombivli East- 421201, Dist. Thane,
Mumbai Area, Maharashtra, India
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