Regulatory Science Section
About the RS Section
The recent AAPS leadership task force, concerning relationships among Section
and Focus Groups since the change in AAPS constitution, has been a challenge to
the Regulatory Science (RS) Section. The Focus groups tend to align with
"parent" large Sections and smaller sections with a broader reach, such as RS,
have more difficulty in liaising. In this article the RS section executive
defines relevant terms and distills section objectives, hoping to inform the
broader AAPS membership of the impact of RS in pharmaceutical research and
development.
Regulatory science in drug development involves all the multidisciplinary
pharmaceutical and allied medical sciences applied to determining the safety,
efficacy and quality of drugs and drug products. Research for regulatory
science includes development and validation of new techniques for emerging
technologies and maintenance or improvement of established methodologies.
Regulatory affairs comprise making efficient plans to apply regulatory science
in developing drugs for timely access to patients of safe and effective new
drug products, within the boundaries established by regulatory, medical and
public partners. In essence, if experiments, techniques and processes presented
in regulatory filings are not included in a general regulatory development
plan, approval delays and even rejections may ensue.
The above indicate the broad reach of regulatory affairs and the following
goals declare how the AAPS, RS section will continue activities and especially
improve interactions with other sections and Focus Groups.
The RS section:
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Provides a forum for scientists and regulatory professionals to discuss the
impact of emerging scientific developments and technologies on existing,
proposed or contemplated tests, standards, guidelines and regulations;
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Promotes communication, understanding and cooperation through focused dialogue
among scientists and regulatory professionals in the pharmaceutical industry,
academia and regulatory industries worldwide;
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Strives to formulate and present scientific positions to regulatory agencies
worldwide to assist them in development of guidelines or regulations that
reflect leading edge pharmaceutical science in balancing risk/benefit
considerations for drug assessment;
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Involves its members within AAPS in planning organizing domestic and
international scientific symposia, workshops, discussion groups, and
educational programs designed to integrate regulatory perspectives into
pharmaceutical research and development.
Iain J. McGilveray, Ph.D. Chair RS section
September 3, 1999
Message from the Section Chair
Dear RS and AAPS members:
Ever since the inception of the Regulatory Science (RS) Section (formerly known
as Regulatory Affairs), there has been tremendous interest among the members to
actively contribute to our efforts. Formed with the intent of integrating the
science of drug development with the regulations that govern the approval of
drugs, devices and biologics, our section has sponsored events that have
significantly contributed to fostering the understanding of new guidelines or
regulations.
Over the last few years this section has sponsored or co-sponsored interesting
and stimulating topics in the form of round tables, symposia, and workshops
that have advanced the process of drug, device and biologics development/drug
regulation. With the growth of our organization and the rapid increase in the
rate of new guidelines and regulations being generated by FDA and other
regulatory agencies under the ICH umbrella, there is an ever-growing need to
integrate rapidly evolving science with regulatory policies and guidances. As
members of the Regulatory Science Executive Committee, we strive to ensure that
our academic, industry, and regulatory colleagues are well informed about
regulatory activities that will impact the process of drug, device and
biologics development.
We aim to provide forums for scientific debate, ensuring that leading experts
have the opportunity to share their viewpoints and experiences. Such debate is
essential to the scientific integrity of the rapidly evolving regulatory
landscape. To keep pace with the changes in our profession, there remains a
high demand for the support and cooperation of our colleagues. Hence, we
request all AAPS members and other interested parties consider the regulatory
science concepts and their impact on particular areas of interest. The RS
Section encourages scientific collaboration, as evidenced by the diversity of
subjects covered by the events associated with our section. We extend an
invitation for support in organizing symposia, short courses, and workshops.
We look forward to your active participation in RS-related sessions at the 2001
AAPS Annual Meeting. To find out more about upcoming regulatory activities and
learn about exciting opportunities, please visit the RS section website at
www.aapspharmaceutica.com/resources/sections/rs.
Vijay Tammara, Ph.D.
RS Section Chair
2001 RS Section Officers and Committee Chairs
2001 RS Section Officers and Committee Chairs
Chair/Workshops
Vijay Tammara
vijay.tammara@sanofi-synthelabo.com
Chair-elect
Joe Mastronardy
joemas@msn.com
Vice-Chair
Marilyn Martinez
mmartin1@cvm.fda.gov
Past-Chair/Nomination
C.T. Viswanathan
viswanathan@cder.fda.gov
Sec.-Treas/Short Course
Uday Kompella
ukompella@hotmail.com
Awards Committee
Vijay Tammara
Uday Kompella
Education
Srikumaran Melethil
melethils@umkc.edu
Paper/Poster Screeing
Gopi Vudathala
vudathala.gk@pg.com
Fellowship
Jerry Skelly
jeromepskelly@msn.com
By Laws
Chris Bapatla
chris.bapatla@alcon.com
Membership/Homepage
Nirdosh Jagota
Jagotan@war.wyeth.com
Education
Srikumaran Melethil
melethils@umkc.edu
AAPS Staff Liaison
James Greif
greifj@aaps.org
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