Indian Biosimilars Market

India is one of the biggest sources of generic industry and is one of the emerging markets with its high population and investment in technology. Although India does not have stringent regulations, the country has a big potential for biosimilars… 
If we have a look at the sales figures of Indian biosimilars, 200 million US dollars of sales was recorded in 2008. But according to the analysts, the market will grow to 580 mUSD in 2012, which means a CAGR +30%.
REGISTRATION OF BIOSIMILARS
As described, India is a semi-regulated market and no phase I/II studies are required for biosimilars. To conduct a phase III study is a mandatory step and minimum 100 patients are needed for this study.
Due to the legislation and the environment in the country, the development of a biosimilar can be between 10-20 mUSD in India, much cheaper than the fully regulated countries. And with this regard, the price of a biosimilar, can be 25-40% cheaper than the originator.

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Advanced drug delivery systems: Nanotechnology of health design A review

Nanotechnology has finally and firmly entered the realm of drug delivery. Performances of intelligent drug delivery systems are continuously improved with the purpose to maximize therapeutic activity and to minimize undesirable side-effects. This review describes the advanced drug delivery systems based on micelles, polymeric nanoparticles, and dendrimers. Polymeric carbon nanotubes and many others demonstrate a broad variety of useful properties. This review emphasizes the main requirements for developing new nanotech-nology-based drug delivery systems.

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Research Coordinator-LV PRASAD EYE INSTITUTE -Hyderabad / Secunderabad

CTC: 2,50,000 - 3,75,000 P.A 

Job Description

 

1. Prepares study materials including ethical committee or regulatory submission documents, enrollment logs, adverse event reports, and staff training materials.
2. May assist in recruitment, training and supervision of research staff.
3. All communications related to project with partners and funding agencies.
4. Prepare reports financial, project progress etc.
5. Arrange, organize, communicate and prepare minutes of research group.
6. The project involves conducting workshops. It will involve arranging venue, communicating with participants, travel and lodging arrangements etc.
7. Maintaining all study files.
8. Back up of all E-research data.
9. Internal communicates- finance, progress reports; publication etc.

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy

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HOS Data Entry-any Grad-Accenture-Chennai

Job Description

Schedule : Full-time

Responsible for the review and validation of eligibility information received from the customer as well as the data-entering of this information into the client system.
Responsibilities/Authorities :

? Complete review of enrollment forms
? Identify missing information on forms
? Send incomplete forms back to client
? Complete and forward outgoing correspondence when required
? Key enrollment forms into client eligibility system
? Maintain customer eligibility information
? Review and analyze specific eligibility report
? Maintain and track individual workflow and production
? Support inventory control during peak times or as needed
? Processes faxed eligibility maintenance requests initiated by Customer Calls
? Process urgent requests
Requirements:
? University degree or equivalent.
? At least 6 months experience as a Processing Assistant preferred, but not required
? Outsourcing operations experience preferred, but not required
? Working knowledge and experience with computers and internet
? Technical or Specific Skills (e.g. technical, computer)
? Basic technical knowledge
? A working knowledge of MS Office products
? Proficient in report writing, business correspondence
? Strong Excel skills

Mandatory Requirement

1. At least 6 to 12 months work experience in healthcare domain as per required domain
a. Claims
b. Billing Function
c. Enrollment
2. Should have past experience working in night shift
3. Should be open to working in night shift
4. Good English comprehension -- verbal and written
5. Simple analytical skills
6. Good typing skills, at least 30 wpm at 95% accuracy
7. Residence should be within Accenture Transport Boundary
8. Should at least be a graduate

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Clinical Research Associate-Manipal Acunova Ltd.-Bengaluru/Bangalore

Job Description

 

The responsibility of a Clinical Research Associate (CRA) is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

Worked in OPHTHALMOLOGY or ONCOLOGY or DIABETES studies Clinical Studies I-IV
Ability to interact professionally with clients/vendors
Excellent interpersonal, verbal and written communication skills and ability to work in a team
Effective time management skills and prioritize tasks to manage study timelines
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills
Willing to travel a minimum of 65% on average



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Research / Clinical / Medical / Non Clinical / US Healthcare - 10 Opening(s)-Hyderabad / Secunderabad

ESSENTIAL JOB RESPONSIBILITIES:

Accurately responding to research related queries and proposing suggestions for rule changes if applicable.
Develop potential rules that can be applied for iHT clients to adjudicate claims accurately relative to medical policy. Review State Medicaid guidelines to identify possibility of inappropriate edits for Medicaid claims.

RELEVANT EXPERIENCE & EDUCATIONAL REQUIREMENTS

- Medical degree (MBBS or MD) / Certified medical coder / BHMS / BAMS
- Clinical experience is a must
- Clearance of all major exams (SSC, HSC, qualifying degree) in first attempt
- Clearance of cognitive aptitude test analytical, quantitative, and logical reasoning skills
- Experience in private sector/ Health plan operations with focus on reimbursement and/or claims processing and/or medical coding preferred
- Knowledge of ICD-10 coding preferred 

Contact Person: Mohsin

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