CLINIMINDS
Cliniminds is an innovative clinical research academy providing a wide range of
clinical research training solutions to the students, pharmaceutical companies,
CROs and healthcare companies in India and other parts of the world.
Cliniminds was established in year 2004, by a group of professionals from Clinical
Research, Pharmaceutical industry and Healthcare industry with rich and varied experience
at top levels. Company was set up with the objective to offer training solutions
in the field of clinical research, pharmaceuticals and healthcare. Cliniminds today
is one of the best clinical research training academy offering world class workshops
and corporate training programs to Corporates and Individuals in India, USA, U.K.,
Canada, Africa, Asia and Middle East.
THE WORKSHOP
Medical writing has gained a phenomenal momentum in drug development today. A Center
Watch market research study shows the medical writing market has grown 15% each
of the last two years, making it a $400 million market. The demand for professionals
trained in writing for regulatory submissions far outstrips the supply.
This area is an extremely important part of drug development process.
A good quality medical writing can often cut short the delays encountered in drug
submission and approval by the regulatory authorities.
With the deluge of clinical trials, more and more drugs are in pipeline for regulatory
approvals making this area much sought after.
Although the term 'medical writing' is very broad, it mainly involves writing associated
with clinical trials, scientific literature, regulatory submissions, pharmacovigilance,
and marketing or promotional literatures.
WHO SHOULD ATTEND
This workshop has been intended for professionals who are keen to enter into medical
writing field and also for those who are into this field and want to enrich their
knowledge and learn the advanced skills of effective writing.
TOPICS COVERED
- Introduction to Scientific/ Medical Writing
- Developing key computer Skills
- English writing basics
- Documents in Medico-marketing
- Reporting Evidence based medicine (EBM)
- Preparing leave behind literatures (LBL), Visual aids, Brochure
- MR training manual, Brand calling card.
- CME for doctors
- Web content, audio-visual aids, CDs.
- Medical Writing for Clinical Research Related Documents (Protocol, Informed Consent,
Clinical Study Report, Annual Safety Report)
- Handling statistics in medical writing
- Referencing guidelines and taking software's help.
- Legal / Copyright Issues in Medical Writing
- Association and organization for Medical Writers
- Medical Ethics in scientific writing.
- Writing Efficacy and Safety Reports for foreign submissions
- Publication writing
- Structure of a scientific paper
- Electronic submissions
- Abstract for scientific meeting
- Case report
- Review
- Ethics of publication
- Guidelines (e.g. CONSORT, ICMJE, GPP)
WORKSHOP OBJECTIVE
On completion of this workshop, participants will have an understanding of the requirements,
roles and responsibilities of medical/scientific content writers. Skills in language,
scientific communication, and data presentation will be enhanced and the expertise
and knowledge will enable writers to prepare drafts that are clearly written and
follow the relevant guidelines.
KEYNOTE SPEAKERS
Dr. Rohit Arora
Dr. Rohit Arora is an MD in Pharmacology and is currently working as a Deputy Medical
Director in the vaccines division of the Sanofi Aventis group. He has extensive
experience in Medical Writing, Medical and Public Affairs, Clinical Research and
Regulatory Affairs. He has been a faculty for many workshops and symposia’s in clinical
Research and Public Health. He has also been an active contributor on nationally
and internationally acclaimed market and business research reports.
Ms. Deepti Goel
Deepti Goel has over 9 years of experience in clinical research working with Pharma
companies, CRO and training academy. By Training, she is an M.Pharm with specialization
in Pharmacology. She has worked across various clinical research verticals including
clinical operations, quality assurance and training. She has monitored, managed
projects, mentored teams and trained clinical research professionals.She has developed
protocols, ICDs, IBs for clinical trials on various therapeutic indications. She
has also written Clinical research articles in various reputed International and
Indian journals. She is a regular Clinical research writer in Chronicle Pharmabiz
magazine. In her current assignment she is the Head of Training and Operations at
Cliniminds and is responsible for oversight of operations and training needs and
development across India.
Dr. Amit Garg
Dr. Amit Garg is MD Pharmacology. Dr. Garg is heading Medical Affairs department
at Merck India. Dr. Garg has extensive experience in the field of medical writing
for the pharmaceutical and clinical research industry.
Dr. Shivamurthy Nanjundappa
Dr. Shiva Murthy, our clinical development leader in India, has more than 10 years
experience in drug development and has worked on more than 120 clinical projects.
The client list includes: Merck Sereno, Astrazeneca, Sanofi Aventis, Astellas, Merz,
Daiichi-Sankyo, Ranbaxy, Cipla, Lupin, Zydus Cadila, Microlabs and Strides Arco
labs. This experience includes conducting Pre-clinical trials, Phase 1, 2, 3 and
4 trials, BA/BE trials and Pharmaco-epidemiology projects.
Dr. Murthy has also developed clinical research departments in India for ICON, Fortis
and Lotus. He has undergone training in GCP, BLS, ACLS, Clinical operations, Pharmacogenomics,
Pharmacovigilance, Medical Affairs related activities. He has the professional membership
in Indian Pharmacologists Society, and he is the one of the official reviewers for
Indian Journal of Pharmacology. He is the advisory board member for Clinical Trial
Magnifier, an online journal published by Clinical Trials Center, The University
of Hong Kong.
SCHEDULE
20th – 21st March 2010 (Saturday & Sunday) 9AM - 5PM
REGISTRATION FEE
Rs.10,000/- (Fee includes Lunch; beverages, workshop folder and certification)
PAYMENT MODE
By Cash or Bank Draft/Cheque favouring 'Tenet Health Edutech Pvt. Ltd.'
CERTIFICATE
Certificates of Participation will be issued to all participants.
VENUE
To be decided