Invites you to a

One Day Free Awareness Workshop

24^th May 2014

11.00 AM to 1.00 PM

Fundamentals of Drug Discovery / Clinical Trial Process & Careers

WORKSHOP OVERVIEW

This workshop will deliver information on the stages of drug discovery and development and especially will provide in-depth knowledge about phases of Clinical Trials and its process.

Speaker: Dr. Smita Singh

Kindly share this invitation with your friends and help them be a part of the same.

Free Registration

On spot registration at 10:00 AM

For pre-registration, contact: 080 49203714 / 715 / 716 or Email us at smita.s@acriindia.com

ACRI-Clinical Research Institute

#33, 3rd Flr, 15th Cross, 100ft Outer Ring Road, 2nd Phase J.P. Nagar, Bangalore – 560078

Ph: 080 26588910

www.acriindia.com

Group Discussion topics for Batch-22 are

''REGULATORY CHANGES IN INDIA AND ITS IMPACT''

''PHASE V IN CLINICAL TRIALS - HOW IS IT DIFFERENT FROM OTHER PHASES''.     

Medical Writing Industry: A Promising Future

Indian Pharmaceutical industry has moved a long way from an infancy industry to a much prized industry since the time Pharmaceutical industry started delegating various responsibilities to the contract research organizations. Pharmaceutical companies fundamentally spend millions of dollars in order to bring an effective molecule to the market, hence it is imperative to assign the duties to CRO thus making the Pharma industry more economical, organized and competent.

The various duties which are delegated to the CRO by pharmaceutical companies are - performing site management, clinical trial analysis, monitoring, clinical data management, pharmacovigilance and medical writing.

Medical writing service is one of the services that has shown tremendous growth over the past years. Demand for medical writing service is rising at a time when major pharmaceuticals have cut jobs.

Medical writing is the process that translates the work of research of Health Care Practitioner or Scientist into a written content.

Medical Writing is of two types:

Sl. No.	Regulatory Writing	Scientific Writing
1	Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics.	Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals
2	Regulatory documents can be huge and are formulaic.	Concise and simple
3	They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and CTD	These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, and programs and enduring materials for continuing education (CE) or continuing medical education (CME).

Why Medical Writing? 

As long as regulatory authorities continue to require an increasing amount of documentation as part of the drug approval process, industry experts believe the demand for medical writing will continue to grow.

The characteristics of a medical writer are-

      Scientific Knowledge
      Ideas
      Represent data in its best presentation
      Distinguish good science and bad science
      Organize information

Qualification:-

Both Health Science and Life Science   Graduates

Employers and clients for scientific medical writers-

•         Academic medical centers
•         Associations
•         Contract research organizations
•         Foundations
•         Hospitals/Health care systems
•         Managed care organizations
•         Medical advertising/communication agencies
•         Medical education companies
•         Pharmaceutical companies
•         Publishers
•         Web sites

Challenges:-

The biggest challenges medical writing industry faces are:

Plagiarism

Plagiarism remains an ongoing moral and ethical concern in the medical communications industry, specifically, the World Association of Medical Editors (WAME) defines plagiarism as -

“…the use of others’ published and unpublished ideas or words…without attribution or permission, and presenting them as new and original rather than derived from an existing source…

There are two ways through which we can restrain plagiarism are-

• ·         Peer Review
• ·         Software

Lack of skills in this area has even been identified as the cause of 
failed mergers

Lack of cross cultural communication

Stringent Regulatory approval Process

Even though Clinical research industry has gone through numerous rise and fall and amendments during recent years nevertheless the industry is working endlessly to improve the standards of regulations and guidelines in India.

A recent market analysis by Center Watch concluded that the market for medical writing had doubled in five years, from 345 million dollars to approximately 700 million dollars. With the continuing difficulties of the economy, it’s hard to find a field that has enjoyed this kind of growth.

Site jobs would have cut off but the CRO industry is still thriving because of pool of talented people, English speaking people and strong IT sector .The result of which the multinational companies are contracting the Indian CRO Companies to achieve the task in economical and timely manner.

ACRI offers Post Graduate Diploma course in Clinical research and  Medical Writing which would benefit students to be partaker of Clinical research industry and also at the same time it would provide an opportunity to the candidates to develop their skills and also implement the expertise by working in various kinds of medical writing project.

Mamatha of batch-21, gave a good presentation on a technical topic of “APPLICATIONS FOR DRUG APPROVALS’’.

Dhinesh of batch-21, gave a very good presentation on a new topic of “WHITE PAPER”.

Introducing Mysore University Courses at ACRI

As the Indian population grows at the rate of 1.5% every year, the requirement for the jobs will drastically increase. As a result of this, government spending will increase in various sectors and one of them is Pharma & Clinical research.

As per as McKinsey report, government spending in healthcare will increase significantly. It has been growing at 18% annually since 2005 to 2006, and is translating into a higher level of access in Tier-II and rural markets.

Secondly, there would be a demand for new therapies and innovative drugs due to aggressive players in market. 

Sl. No.	THERAPIES	GROWTH
1	OTC/Self-medicate	Growth over 14% annually
2	Biologics	3 billion segment by 2020
3	Vaccines	20 per cent over the next decade

In the base case scenario, all the important growth drivers will observe vigorous progress. The market will grow more than four times to reach USD 55 billion by 2020. 

As the Indian population grows, the prevalence of diseases like diabetes, cancer, heart disease etc. will also show drastic increase.

Insurance coverage would grow to cover the entire Indian population below the poverty line.

Moreover, the players will influence the patient funnel by increasing awareness and treatment, thereby increasing the patient pool by 15 percent.

Beyond numbers, new skill requirements will also increase the attractiveness of talent from Pharma and non-Pharma backgrounds. The Post Graduate Diploma in Clinical Research and Clinical Database Management program at ACRI (Mysore University) invites BSc, MSc in life science and health science to join the course and enjoy different opportunities’ offered by Pharma and CR industry.

Batch-21 students of ACRI, gave a very informative presentation on the technical topic of “ICMR”.