Clinical Research - Transforming lives: 2021 and beyond Pre-conference Workshop MEDICAL WRITING: Effective Authoring of Clinical Study Reports ...
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14th ISCR Annual Conference
Clinical Research – Transforming lives: 2021 and beyond
Pre-conference Workshop
MEDICAL WRITING: Effective Authoring of Clinical Study
Reports (CSRs) in the Evolving Landscape of Data
Transparency
Schedule: 12th March 2021
12:00 hrs to 20:00 hrs.
Speakers Biosketch
Dr. Hetal Shah
Founder-Director, MeWriT Healthcare Consulting
Hetal Shah is a PhD Pharmacologist with over 17 years of professional experience in the field of clinical
research and medical writing.
She is the Founder-Director of MeWriT Healthcare Consulting, based at Ahmedabad, India; and
provides independent medical writing support for authoring complex regulatory documentation,
scientific publications, and medical communications to multinational Pharma and CROs.
www.mewrit.com
Hetal has been felicitated as ‘Woman Entrepreneur in Pharma & Healthcare 2019’ by AIC – LMCP
Foundation, supported by Atal Innovation Mission, Government of India.
Multiple gold medallist for her manifold academic achievements, Hetal has > 60 national and
international scientific publications to her credit. She is a GCP-trained professional, with a rare
combination of hands-on experience on global clinical studies at investigative sites as well as CROs. She
also serves as a Pharmacologist and Clinical Expert for clinical study design and protocol development
14th ISCR Annual
aspects, study reporting and regulatory responses.
Conference
An adept trainer with practical approach to coaching, Hetal also independently conducts medical
writing trainings & workshops; and is a frequent speaker at scientific conferences.
Pre-conference
Hetal is currently an active member of ISCR (MW Council); and the Medical Writers group of India.
Workshops
On a personal front, Hetal is a passionate trained dancer performing Bharatanatyam, Kathak and
12-13 March 2021 multiple Indian dance forms, a yoga fanatic with her eternal love for Suryanamaskaras, and a culinary
enthusiast in her free time.
Dr Samina Hamilton, Keynote Speaker
Global Head, Medical and Regulatory Writing
and Public Disclosure, Clinipace
Sam Hamilton is a postdoctoral virologist, currently Global Head of Medical and
Regulatory Writing and Public Disclosure for the CRO, Clinipace
https://www.clinipace.com/.
With over 25 years in clinical and regulatory medical writing roles in the pharmaceutical
industry, Sam has a special interest in the area of public disclosure of clinical-regulatory
documents as Chair of the EMWA-AMWA group who delivered the open-access
www.core-reference.org in May 2016.
Sam is long-time supporter of EMWA serving in various roles over 14 years, notably as
Freelance Advocate; Editorial Board member for Medical Writing (MEW; journal);
14th ISCR Annual Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President of
Conference the Executive Committee (EC). Sam is currently MEW Section Editor for the “Regulatory
Public Disclosure” Section and on the Advisory Panel of the Regulatory Public Disclosure
Special Interest Group.
Pre-conference
Workshops Sam was elected an EMWA Lifetime Fellow in 2018 for her services to the association
12-13 March 2021 and the global medical writing arena.
Divya B P
Team Leader, Exploratory Medicine and Pharmacology,
Global Scientific Communications, Eli Lilly Services India Pvt Ltd
Divya is a postgraduate in Medical Physiology from Kasturba Medical College, Manipal and has a
post graduate diploma in Bioinformatics. During her school days, Divya won in the National Science
Seminar and represented India at a Space Camp at NASA. During her graduate days she received a
summer research fellowship at Indian Institute of Science in the developmental biology and genetics
laboratory.
Divya comes with extensive experience in writing regulatory documents for vaccine, new drug
development (Phase I to IV including PMS studies), epidemiology studies and more recently clinical
pharmacology. Her experience also includes leading and writing large narrative writing projects and
mentoring new Medical Writers. She has also been a peer reviewer for regulatory documents.
In 2005, Divya started her medical writing career at GSK, Bangalore in the vaccine division. After this
Divya worked as a freelancer for GSK and other clients. She also took on a small medical writing
14th ISCR Annual venture and even wrote story boards for animation. In 2011, Divya moved to a CRO setup with
Conference Quintiles (now IQVIA) as a medical writer. In January 2016, Divya joined the Global Scientific
Communications group at Lilly Capability Centre India 2016 as one of its first employees. In Lilly,
Pre-conference Divya has extensively worked with EMP and led the submission from EMP for the recently approved
ultra-rapid insulin lispro, LYUMJEV. Currently Divya leads the EMP hub at Lilly, Bangalore.
Workshops
12-13 March 2021 In her free time, Divya loves reading books of any genre, baking and travelling. Divya lives with her
husband of 18 years, a teenage son and a laboratory released Beagle.Annie Jose
Medical Writing Specialist,
Novo Nordisk Global Business Service, India
Annie Jose, Medical Writing Specialist at Novo Nordisk, has more than 13 years of
experience in the core regulatory medical writing.
Annie holds a Masters in Biotechnology and a Diploma in Clinical Research from the
University of Pune.
At Novo Nordisk, she functions as clinical submission team lead and a project medical
writer.
She has extensive experience in leading and driving the preparation of wide range of
regulatory documents. She is a subject matter expert for plain language summaries.
14th ISCR Annual
Conference Prior to Novo Nordisk, she worked for different organizations like Kinapse, GVK bio,
PAREXEL and TCS.
Pre-conference She is a member of All India Medical Writers Association (AIMWA) and the DIA Medical
Workshops Writing Group of India.
12-13 March 2021Dr. Jully Garg, PhD
Senior Medical Writer
Novo Nordisk Global Business Service, India
Dr. Jully Garg is a passionate medical writing professional with a decade of expertise in
scientific/medical writing and clinical data transparency.
She holds a PhD in Molecular Oncology and MTech. in Biotechnology with premiere
institutes.
She joined Novo Nordisk (India), Medical Writing unit in year 2013 and currently
responsible for Clinical Transparency functions.
She is a subject matter expert for Plain Language Summaries writing of CSRs.
14th ISCR Annual Prior to Novo Nordisk, Dr. Garg was associated with Novartis, Global Medical Affairs,
Conference Oncology unit (India).
She has been granted a patent at NCBI for a unique patient derived novel gene
Pre-conference sequence.
Workshops
12-13 March 2021 She has published her Oncology research in renowned journals.You can also read
