Students Notes

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VPM's
ADVANCED STUDY CENTRE

 


 

COURSES OFFERED :


PART TIME : POST- GRADUATE DIPLOMA COURSES IN :
1) APPLIED ANALYTICAL CHEMISTRY
2) REGULATORY AFFAIRS
3) HORTICULTURE & FLORICULTURE BIOTECHNOLOGY
4) APPLICATIONS OF STATISTICS

 

1) APPLIED ANALYTICAL CHEMISTRY:
Many talented graduates wish to pursue higher education. However, their aspirations are stifled due to limited number of openings available. Even for the sake of employment they are not adequately equipped or suitable oriented to meet the demands of the industry.

With the increase in quality awareness and development of sophisticated instruments, there is growing need of properly trained Analytical Chemists in the chemical industries. The said course is designed in consultation with the experts in the industry, as per their expectations from analytical chemist, thus ensuring good employment potential for the course.

The course includes modules like Fundamentals of Analytical Chemistry, Quality Control, Quality Assurance, ISO 9000, ISO 14000, Kaizen, Sampling, Flame Photometry, NMR, Electro Analytical Techniques, Thermal-TGA & DSC, Viscosity, GC, HPTLC, FTIR, Atomic Absorption Spectroscopy (AS), Ion Exchange, Classification of Pollution and Pollutants, Sampling Methods, Significance & Analytical Determination of BOD / COD, Monitoring of ETP, Hazards in handling of laboratory chemicals, Fire Triangle, Preventive Measures, Personal Protective Equipments etc.

2) REGULATORY AFFAIRS:

Regulatory Affairs (RA) also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices and energy.

The Pharmaceutical, Biotechnology and Medical device research and development industries are most highly regulated industries in the country. As India is growing very rapidly in the pharmaceutical sector, there is a growing need of regulatory affairs professionals to cater the current needs of industries for the global competition.

Regulatory Affairs Officers are the crucial link between their company, its products and worldwide regulatory authorities including MHRA, USFDA, EMEA. They ensure appropriate licensing, marketing and legal compliance of pharmaceutical and medical products. They combine scientific knowledge, legal and business issues and co-ordinate the approval and registration of pharmaceuticals, veterinary medicines, complimentary medicines, chemicals and pesticides.

Our course is designed as per FDA requirements to cater the need of expertise in the field of pharmaceutical regulatory affairs. The students and professionals currently employed in pharmaceutical / chemical industries will gain a thorough understanding of current regulations and their applications to the development and commercialization of drug, biologic and bio-device products.

The trained students can get the openings in the companies that develop and manufacture pharmaceuticals, chemicals, veterinary, herbal, homeopathic prodcts and medical devices as a Regulatory Affairs Officer, Analyist, Information Officer / Manager, Information Scientist, Research Scientist, Technical Author etc. The working professionals will upgrade their knowledge and skills, which will help them climb the ladder of success in their careers.


3) HORTICULTURE & FLORICULTURE BIOTECHNOLOGY:
Maharashtra is fortunate to have varied agro climatic zones in the state spread over various soil types, supporting cultivation of different and large number of crops including horticulture. If we exclude the industrial belts, the major part of the state depends on agriculture. In order to sustain, to have self-employment and to develop our economy in this competitive world, commercial agriculture is the need of this century. Maharashtra state government has taken initiative in increasing area under horticulture crops cultivation under employment guarantee scheme.

Advanced Study Centre's Post Graduate Diploma in Horticulture aims at study of different aspects of horticulture. The beauty of the course lies in the fact that one can assured self-employment in any of the major topics of horticulture that have been discussed below in brief. Horticulture is a vast field and has tremendous scope for monetary returns.
Study of vegetable growing is one of the most important topics that will be dealt in detail keeping its commercial importance in view. Commercial cultivation of flowers has recently turned out to be a subject of great interest as it ensures quick monetary gains and above all adds to the beauty of the nature.

Spices, condiments, medicinal and aromatic plants have been a source of revenue since past and their importance is increasing these days for their medicinal properties and due to the fact that their use doesn't have any adverse side effects. Post harvest management covers study of maturity, harvesting and handling in relation to the shelf life and quality of fruits, vegetables and flowers. Functional uses of garden design, home landscaping, school garden, urban, state and national parks. Industrial landscaping, roadside planting, rock gardens, lawns have been included in landscape gardening. Besides, the students are prepared in the techniques of Bonsai, Ikebana, Composting and Bio-fertilizers.

Greenhouse technology and plant tissue culture are very popular these days and due coverage has been given in the course. Visits to nurseries aim at acquaintance with propagation techniques. Practical in food processing will cover different recipes and storage technology.
Successful completion of theoretical and practical aspects of the course will ensure upgradation of knowledge about horticulture to the extent of offering consultancy to absentee landlords and self-employment in any of the topics covered in the syllabus.

4) APPLICATIONS OF STATISTICS:

Indian Pharmaceutical industry has long proved its mite both at national and international arena. With the WTO regime just rising in the horizon our pharma companies are in for a great boom especially in manufacturing and marketing generics.

Typically a new drug takes about one and half decades of R & D to reach the market. An important phase in the drug development process is demonstration of safety and efficacy of the drug in human. This is achieved by conducting clinical trials involving a team of experts from medicine, chemistry, biochemistry, pharmacy, and biostatistics and from regulatory agencies. A typical multi-centered clinical trial may involve coordination of study centers stretched across various parts within a country and various study centers across the globe. The success of such trials is largely based on the quality of trial monitoring, quality of data acquisition and quality of data evaluation. Biostatistics plays an important role in ensuring integrity of data acquisition, data management and data evaluation. It is therefore very important for all the experts involved in a clinical trial to be oriented to best statistical practices. Compliance to Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) is a must for all trials to ensure reliable and authentic results being generated in such studies.

Inadequacy of Trained personnel:
Major hurdle faced by various Pharma. laboratories is the lack of adequately trained personnel oriented to GLP and GCP. The lacunae become more evident when dealing with newer dosage forms and peptide based drugs. The same inadequacy is seen even among the national laboratories and other Testing and research centers.

This lacunae needs to addressed very diligently and the COURSE is a step in this direction. The course is an interdisciplinary programme to generate such expertise among science graduates. Though industry uses sophisticated instruments in QC and drug development, there is a dire need of technical personnel with an overall expertise in various evaluation techniques, especially biostatistics to be able to come up with meaningful conclusions.

The proposed Course has been planned to address this need of trained personnel. The programme aims;

1) To give advanced knowledge of Biostatistics.
2) To provide training for evaluating and managing Clinical Trial Data.
3) To provide hands on training in sophisticated Statistical Software
4) To provide orientation in practice of latest GLP and GCP guidelines.
5) To generate a team of trained professionals who can provide data management services in the drug industry.

The training will also include use and maintenance of related software and statistical packages.

The curriculum covers :
Ø Basic Statistics
Ø Financial Mathematics, Quality Control
Ø Time Series Analysis & Forecasting
Ø Actuarial Science / Clinical Trials / Statistical Validation / Financial Analysis / Marketing

Job opportunities: in Pharma; Chemical Industries, Stock Exchange, Financial Institutes, Marketing Research Institutes etc.