Profile of Dr.
K.Sivakumar, M.Pharm, Ph.D
Introduction
A Pharmaceutical
Technologist by education, with close to 50 years of
experience in the Pharmaceuticals and Medical Devices
industry, with expertise in areas of Production, Quality
Assurance, Regulatory Affairs, Research and Development
and Corporate Management, while working in multinational
industrial organisations. Hold leading roles and
membership in coveted International Standardisation bodies
and regulatory activities. Extensively travelled worldwide
for professional and business meetings. Recipient of
Excellence Award from International Organisation for
Standards (ISO) for achievement and for contribution
towards development and publication of ISO standards.
Professional
Qualifications
Alumnus of Madras Medical College and BITS,
Pilani for qualification in B.Pharm, M.Pharm and Ph.D
degrees.
Alumnus Indian Institute of Management,
Ahmedabad, India, with qualification in Management
Development Programme.
Professional Career
Technical and Management Consultant:
Currently engaged in offering technical and
management consultancy services to Healthcare,
pharmaceutical and medical devices industry, International
procurement and Regulatory agencies, Community
institutions and Academic bodies in the areas of technical
and business development. Managing Director, Pharmedices
Technical Services.
WHO, UNFPA
Expert, Consultant for development of
specifications and technical literature, facilitating
training programmes and workshops in several regions
helping the national regulatory agencies and national
laboratories in building capacity relating to development
and implementation of regulations and testing laboratories
in the fields of pharmaceuticals and medicals devices;
Technical assistance and assessing product technology and
manufacturing capabilities for pharmaceuticals and medical
devices; Development and implementation of
prequalification and post qualification monitoring
programmes for international procurement and distribution
of pharmaceuticals and medical devices.
FHI 360, USA.
Consultant on QA
activities for Global Health Supply Chain (GHSC)
programmes covering pharmaceuticals and medical devices
for United States Agency for International Development (USAID)
and related international agencies, involving product
and technology assessment, onsite manufacturing
capability assessment and review of technical training
and capacity building in the field of pharmaceuticals and
medical devices.
Professional Affiliations
1.
International Organisation for Standards (ISO)
An active member of ISO Technical Committee
157, responsible for setting up International Standards
with membership of about 80 international delegates
representing over 40 countries. Convener of WG14 on
Quality Management, WG 17 on Synthetic Condoms and as
professional Expert in other working groups. Chaired the
meeting of ISO TC 157 at Kuala Lumpur, Malaysia, in 2001.
2.
Bureau of Indian
Standards
Member of Committee on Medical and Hospital
Products, and representing India in ISO TC 157. Developing
Standards and guiding inter laboratory testing programmes
to facilitate development of Standards for medical
devices.
3.
Voluntary Health Services, Chennai ,
India
Member of Central
Committee of Management of 400 bedded multi specialty, non
profit community hospital, involved in development,
management and clinical research in the areas of
healthcare, pharmaceuticals and medical devices.
4.
Indian Pharmacopoeia
Was a member of the
working group for revision of Indian Pharmacopoeia.
5.
Organisation Of Pharmaceutical Producers of
India
Was a member of Technical committee,
responsible for technical development and regulatory
affairs.
6.
Indian Pharmaceutical
Association
Was the Vice President of Tamil Nadu state
branch of Indian Pharmaceutical Association, the
pharmaceutical professional body of India.
Academic
Affiliations
1.
BITS, Pilani, Anna University, Chennai
Visiting faculty, member of Board of
Studies, research projects guide.
