National Conference on Pharmaceutical and Healthcare

National Conference on 

PHARMACEUTICAL AND HEALTHCARE

CHALLENGES & OPPORTUNITIES

April 30, 2013 - Ahmedabad
The Metropole Hotel, Ahmedabad

There is a National Conference on Pharmaceutical and Healthcare : Challenges & Opportunities which is organized by the ASSOCHAM (The Associated Chambers of Commerce and Industry of India) on 30 April 2013 in Ahmedabad (The Metropole Hotel).

Focus Areas

• Market Orientation
• Generic Drug -Clinical Research- Cloud TechnologyRegulatory Affairs & Policy issues
• Patented Drugs & Pricing
• Fostering innovation and Intellectual Property Rights (IPR)
• Drug Licensing

Who can participate                                                                                                             

• MD/CEO/CTO/COOs other decision makers of the relevant Industries
• Bulk Drug Manufacturers
• Pharma exporters-Importers
• Clinicians (Physicians, Nurses, Pharmacists
• and Other Health)
• Formulators/ Production Chemists
• QC/ QA, Regulatory Personals/ Auditors
• Patient Safety Managers
• Educators of Healthcare/ Pharma
• Providers
• Research Institutes
• Trustees of Health Care Organizations
• Health Insurance and Health Plan Executives
• Hospital and Health System Administrators
• Pharma/Biotech/Medical Equipment makers
• Risk Management Experts
• Healthcare Consultants
• Venture Capitalists and Investment Bankers
• Healthcare Attorneys and In-House Counsel
• Health Service Researchers and Health
• Policy Expert

how to register for this Conference                                                                                      

To attend in this Conference click Here to download the registration form. 

For more details go through the official website http://www.assocham.org/gct

Current opening in Parexel

Organization : Parexel

Job Title : Clinical Enrollment Manager

Location : New Delhi (India)

Qualification :To Degree level or equivalent nursing background
Responsibility : 

• Maintain updated patient database plus regular site contact and visits. 
• Collaborate and exchange information with site staff on a regular basis.Collaborate and exchange information with CRAs (as appropriate) on a regular basis.
• Identify opportunities for the LES service to be offered, through an appreciation of the sites¿ needs, awareness of the enrolment needs, information arising out of site meetings.
• Contribute to the development and maintenance of an effective patient database. 
• Review patient notes, select and present high quality, patients to fulfil enrolment needs.
• Review site screening records to identify potential subjects. Work with local centres to facilitate a patient referral process to main centres
• Supply (and coordinate) information for brochures, newsletters, proposals and advertisements concerning the study recruitment.
• Organise spirometry training and co-ordinate other appropriate trainings in co-operation with site staff to ensure continuous development.
• Undertake the full range of duties relevant to the LES to ensure that performance meets and/or exceeds the enrolment for the study.
• Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the site staff in an open, balanced and objective manner.  
• Fixed period of support to the data cleaning activities

To Apply this position Click Here

ORACLE Certified training on Oracle Clinical

APHETA invites the application for the Value Added Oracle Authorized Training on Oracle Clinical from ORACLE University. This is a once in a life time opportunity for the students to build a prosperous future by having great job opportunities in the CLINICAL DATA MANAGEMENT Industries.

 This training Program is for students of pharmacy, biotechnology, medicine, clinical Research professionals and Doctors. The program will cover the essential functional topics using Oracle Clinical Data Management tools and also expose the students to an enterprise scenario through case studies. The Program will be organized by Oracle University. The duration of the course is 40 hours which will be taking place for 5 days, 8 hours per day.

Details of this training are as follows 

Program Name         : Training on ORACLE Clinical

Recognition              : From ORACLE

Certification             : From ORACLE

Duration                   : 40 Hours (8 hours / day)

Mode                        : Full Time (Classroom)

Fees                          : 45000 INR (Including tax)
Venue                       : Apheta, New Delhi (India)

Eligibility for this Training

Bachelor or PG Students from :

• Pharmacy 
• Biotechnology 
• Medicine 
• Medical Professionals 
• Clinical Research 
• Microbiology 
• BAMS, BHMS, BDS, BPT, BMLT 
• Other Life Science Graduates.

Venue for this Training

Apheta Institute of Clinical Research, 389, South Ex. Tower, 201(2nd Floor), Masjid Moth, South Ex. Part - 2, New Delhi - 110049 (India)      

Schedule for this training

Day 1
System Overview, Basic Study Setup
Global Library Management

Day 2
Simple CRF modeling
CRF modeling for PDF

Day 3
Data Entry
Discrepancies, Data Clarification Form

Day 4
Validations and Derivations
Batch Data Loading, Laboratory Overview

Day 5
Data Extract and Access from SAS
Data Locking and Security, Copy Groups.
Simulated Oracle Training content for future practice

Topic Covered in this Training

CRF  Review

Browsing Oracle Clinical

Object in Oracle Clinical

Setup a Program, Project, Study

Planning details, Study Design, Study Statuses

Setup Planned Events

Add Sites, Investigators and Patient Positions

Manage Treatments, Schedules

Create, Maintain Global Library objects

Define & Copy DCM and DCI

Lab Ranges, establish unit of Measure, standard Lab Ranges

Lab Assignment criteria

SQL

PLSQL

Validation Derivation Procedure – Edit Checks

Entering CRF Data

Modify DCI

Discrepancy Management System

Data Clarification Form

Overview of Batch Data Loader

Data Extracts

QC Checking and Data Locking

Case Study (CDM Project assignment)

The Program will be organized by Oracle University and the following deliverable will be extended as a part of the training from Oracle University :

1. Software Environment during the training. 
2. Course Content
3. Training Methodology - Slides 
4. Completion Certificate duly signed and endorsed by Oracle University

Process of Application for this training

To book your seat, call to the following Number OR Visit the Institute

Apheta Institute of Clinical Research
389, South Ex. Tower, 201(2nd Floor)
Masjid Moth, South Ex. Part - 2
New Delhi - 110049
Ph: +91 11 45782279
Mob : +919555718847

 To apply online CLICK HERE 

Benefit of this Training

• Students will become trained by Oracle professionals .
• This will provide an added advantage to their academic qualification. 
• Students will be entertained by all the pharmaceutical, biotech, medical device and clinical data management companies who are working on Oracle. 
• Certificate will be provided by the Oracle University. 
• Diversity in the job prospects for the students. 
• Enormous use of Oracle clinical by the companies, create huge number of job openings in this field

Opening for Regulatory Affairs Manager : Intertek, Canada

Organization :Intertek

Job Title : Regulatory Affairs Manager

Location : Mississauga, ON Canada

Qualification : Minimum B.Sc. (advanced Science university degree, e.g., Pharmacology, Pharmacy or related discipline preferred)

Experience : 

• Minimum of 6 years regulatory experience in Regulatory Affairs.
• Thorough knowledge of new product and process development, current regulatory issues in Canada, United States, and Europe.
• Good technical writing skills and the ability to review and critique safety, efficacy, and quality.
• Excellent interpersonal skill and organizational, time management and communication skills are essential.
• Demonstrated leadership ability.

Job Responsibility : 

As Regulatory Affairs Manager, you will work with other in-house Regulatory Affairs professionals in the day-to-day issues associated with regulatory affairs, such as working actively on projects, writing domestic and international regulatory submissions and strategy documents as well as directing compliance audits and keeping abreast of ongoing changes in regulatory and compliance policies and procedures.

As a member of the Pharmaceutical & Healthcare Group, you will:

• Provide global regulatory affairs consultative support.
• Manage and participate in the writing and preparation of eCTD compliant submissions and regulatory filings related to Rx and OTC drugs (including biologics), medical devices, Natural Health Products, cosmetics, and veterinary drugs.
• Review documents for IND/CTA, NDA/NDS, IDE/510(K)/PMA, PLA, etc. and associated amendments/supplements. This includes the evaluation, and interpretation of proprietary and published safety, efficacy, and quality data. Recommend changes for labelling, manufacturing and marketing for regulatory compliance.
• Be responsible for the management and quality control of regulatory projects.
• Participate in regulatory agency meetings.
• Develop global product strategies for new products.
• Keep abreast of regulatory procedures and changes by attending regulatory conferences.
• Supervise regulatory affairs staff.
• Project manager responsible for regulatory affairs projects being delivered to clients on time, on spec and on budget. Prepare proposals and project budgets to present to clients.
• Assist with the preparation of business development plans for the regulatory affairs area and for the Pharmaceutical and Healthcare Group. 

To see the original notification CLICK HERE