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|
Mildred S. Christian, Ph.D.,
Fellow, ATS |
|
President |
| Argus
International, Inc. |
| 933 Horsham Road, Horsham, PA 19044 USA |
| TEL:
215-672-8867 FAX: 215-672-3619 |
| www.argusinternational.org |
| mschristian@comcast.net |
Consulting services for industry,
regulatory agencies, law firms and professional organizations in the United
States, Europe and Japan on:
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General Toxicology
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Neurotoxicology
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Reproductive Toxicology
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Photobiology
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Risk Assessment
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Behavioral/Functional Teratology
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Developmental (Embryo-Fetal Toxicity/Teratogenicity) Toxicology
Provided by the Regulatory Affairs
Consulting Division
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Audits of reports,
tables and raw data
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Critical phase and facility inspections
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Simulated agency inspections (FDA, EPA, OECD)
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Standard Operating Procedure audits
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Quality assurance unit procedure and record keeping inspections/audits
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Automated data collection systems inspections/audits
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•Train quality assurance
unit personnel
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•Establish, update and historically track Standard Operating Procedures
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•Review protocols
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•Establish critical phase inspection schedules
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•Conduct GLP seminars
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•Establish and maintain archival procedures
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•Conduct training seminars on agency inspections, Standard
Operating Procedure writing and tracking, and inspection/audit
procedures
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•Validate automated data collection programs and equipment
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Position Papers
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Expert Opinion
- Court Litigations
- Agency Hearings
- Expert Panel
Discussions
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Regulatory Submissions (US, Europe and Japan)
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Critical Reviews of
Reports
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Data Tabulation and
Statistical Analysis
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Literature Searches
and Reviews
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Protocol Development
and Audit
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Evaluation of Dosage
Range Studies
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Placement and
Monitoring of Preclinical and Clinical Studies
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Data Analysis and
Preparation of Tables and Reports to GLP standards
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Generation of Journal
Manuscripts from existing studies for
publication in the
United States or Internationally
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Preparation of
Abstracts and Poster Sessions
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•Form 1571
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•Table of
Contents
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•Introductory
Statement
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•General
Investigational Plan
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•Investigator’s
Brochure
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•Protocol(s)
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•Chemistry,
Manufacturing and Controls Data
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•Pharmacology and
Toxicology Data
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•Summary of
Previous Human Experience
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•Additional
Information
NDA Additions
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•Secrecy agreement
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Review existing documents for GLP compliance; and determine and
address deficiencies
- Interact with FDA regarding
timing and presentation of pre-IND meetings and all other required
activities
- Design, conduct and/or monitor
in vitro and in vivo nonclinical studies for scientific
and/or GLP compliance
- Assemble data, prepare IND
and/or NDA, including Investigator’s Brochure
- Contract and monitor clinical
trials
- Submit IND/NDA
•EDUCATION
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Courses in
- All Aspects of Regulatory Affairs and Compliance
- Designing SOPs (Individual and Entire System)
- Toxicology
- Study and Protocol Design
- Risk Assessment
- Study Director Training
- Project Management
- Drug Approval Application Overview
- Updates on New FDA and EPA Regulations
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Lecturers from
- Industry, Academia, Government Agencies
- Internationally recognized scientists and regulators
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Courses and Seminars Customized
for Your Facility
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Courses Presented at Your
Facility
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Argus International -
1993-1995
- Presented a series of courses open to the public to fill an
industry-wide demand
- Lecturers were internationally known leaders in their fields.
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Prior to 1993 and Currently
- Courses Designed and Presented on Request
- Courses Presented at Scientific Meetings
- Courses and Lecturers Provided to Continuing Education
Organizations
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•Network
of Consulting Scientists and Auditors
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•Historical Control Data as
tabulated by Argus Research Laboratories, Inc., for CD rats and NZW
rabbits
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•Validated computer programs for
Statistical Analyses
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•On line communications
COMPANY
PROFILE
HISTORY
CORPORATE
EXPERIENCE
REGISTRY
OF EXPERTS AND ORGANIZING EXPERT PANELS
DOCUMENT
PREPARATION AND PUBLICATION EXPERIENCE
QUALITY
ASSURANCE
CORPORATE
FACILITIES AND EQUIPMENT
HISTORY
Since Argus
International was founded in 1980 by Dr. Mildred Christian, the
organization has provided scientific, management and training expertise to
companies, organizations and agencies in the U.S., Europe and Japan.
Argus International has provided consulting and/or support services to
International Regulatory Groups [the European Community (EC), the
Organization for Economic and Cooperative Development (OECD), the Japanese
Ministry of Health and Welfare (JMHW) and the Australian Ministry of
Health and Welfare (AMHW)], sectors of the FDA, EPA, the State of
California and multiple organizations in the private sector. For any
given assignment or project, Dr. Christian may draw upon an established
network of many prominent specialists who are experts in their fields.
Argus International
provides extensive consulting services for long-term and short-term
projects in project management, information management (collection and
disbursement) and personnel management (organization and the conduct of
expert meetings and panels). Argus International has substantial
experience in providing these services that require overall management of
specific activities and/or site selection and preparation for professional
meetings held in the US and abroad ranging from 5 to 1000 in attendance.
Other commonly requested
services provided by Argus International are preparation of scientific
reviews and position papers, quality assurance audits of various types,
re-calculation and re-tabulation of data for studies conducted by private
laboratories, provision of expert opinions (panel, agency or court),
preparation of INDs and NDAs. In any one year, Argus International
generally manages 20 to 40 projects and contracts for various services
that generate revenues ranging from $2500 to $200,000 per contract.
Argus International frequently works in partnership with other
corporations on specific projects.
CORPORATE
EXPERIENCE
Argus International
provides exceptional capabilities in discerning potential risk to human
reproduction. Argus International has conducted numerous evaluations of
the potential of chemicals and chemical mixtures, as well as
pharmaceuticals, to adversely impact human development and reproductive
capacity. Dr. Christian and other scientists associated with Argus
International have served extensively on expert panels and review
committees in the US and around the world. In addition, Argus
International has experience and expertise in project management, quality
assurance, training courses, expert panels, symposia, development of INDs
and NDAs, literature search and reviews and manuscript preparation and
publication.
Argus International has considerable experience in:
(1) reproductive and developmental toxicology, general toxicology, human
health risk assessment, (2) maintaining a registry of experts and
organizing expert panels, (3) computer and database experience, (4)
conducting literature searches and retrieval, and (5) preparing and
publishing documents and (6) quality assurance and other regulatory
services.
Project
Management.
Companies whose own resources may be stretched, who have limited
experience and expertise in specific areas, or may be from a company
outside the U.S., frequently call on Argus International to manage major
projects like IND or NDA submissions. Argus International can manage the
communications, monitoring, study/laboratory selection, required personnel
and paperwork on an "as needed" basis saving the company time, money and
effort.
Training
Courses.
Scientists associated with Argus International have designed and presented
courses to companies and professional organizations specifically to train
individuals. Some topics include product and project management in developing pharmaceuticals, devices and chemical products, changes in nonclinical and
clinical testing requirements (especially developmental and reproductive
toxicology, neurotoxicology and photobiology), regulatory requirements
for submissions, facilities, archives, Good Laboratory Practices, Good
Clinical Practices and Good Manufacturing practices. Argus International
personnel manage site selection, all preparation for course participation
and attendance. In any given year from 5 to 30 courses are presented with
registration ranging from 5 to 600.
Expert
Reports, Reviews, and Testimony.
Consulting scientists have provided extensive reports, reviews and
testimony on human and environmental risk assessment for clients (US,
Europe, Japan, China and Australia) in private industry, government
agencies, legal firms and expert panels on a wide range of subjects
including chemicals, pesticides, drugs and pharmaceuticals, water and
potentially toxic substances.
REGISTRY OF EXPERTS
Argus International
maintains a large registry of experts with various specialties. A working
relationship for this network is maintained through many means of contact
including: working on specific projects; membership in professional
organizations and societies; participation in symposia, workshops and
committees and contact with key personnel in industry, academia and the
agencies. An impressive number of scientists with experience and
expertise in various areas of toxicology (especially
reproductive and developmental) and risk assessment are currently under
Confidentiality Agreement with Argus International. The staff at Argus
International has successfully planned and presented numerous symposia,
expert panels and other meetings on a wide range of topics.
DOCUMENT
PREPARATION AND PUBLICATION EXPERIENCE
Desktop
Publication.
Argus International has extensive in-house desk-top capabilities including
experienced staff, appropriate software and necessary computers and
printers to produce any type of document (electronic, hard copy, slides,
manuscripts, programs, instruction manuals, course books, posters, etc.).
Reports and
Data Tabulation.
Data from studies conducted at other facilities are frequently sent to
Argus International for analysis and interpretation. Additional
tabulation and statistics can be performed.
Manuscript
Preparation.
Dr.
Christian is author of more than 110 scientific papers and has contributed
to several major text books. The majority of these manuscripts have been
processed through Argus International. In additional Argus International
has prepared manuscripts for publication for major pharmaceutical
companies and associations including Wyeth-Ayerst, Robert Wood Johnson
Pharmaceutical Research Institute, the Soaps and Detergents Association
and the Chemical Manufacturers Association.
Journal
Publication.
During the 10 years that Dr. Christian served as Editor-in-Chief of the
Journal of the American College of Toxicology, the staff of Argus
International solicited and prepared manuscripts, handled the peer review
process, and provided the documents to the Journal publisher meeting
publication deadlines for six volumes per year.
Course
Materials.
Argus
International has extensive experience in the preparation and distribution
of course materials (presentations, workbooks, course notes etc.).
QUALITY ASSURANCE
Argus International can
provide GLP compliance consulting services in two manor areas, audit/
inspection services and quality assurance unit services. Inspection/audit
services include: audits of reports, tables and raw data, critical phase
and facility inspections, simulated agency inspections (FDA, EPA, OECD),
standard operating procedure audits (including corrections and maintenance),
quality assurance unit procedure and record keeping inspection/audits and
automated data collection systems inspections/audits. Quality assurance
unit services include: training, establishment, update and tracking of SOPs,
review of protocols, establishment of critical phase inspection schedules,
conduct of GLP seminars, establishment and maintenance of archival
procedures, conduct of training seminars on agency inspections, SOP writing
and tracking, and inspection/audit procedures.
Argus International
managed the complete overhaul and establishment of SOPs for a pharmaceutical
company to bring it up to GLP standards. Argus International consultants
worked with company scientists and personnel to revise and supplement their
skeleton set of SOPs so that GLP standards could be met. Argus
International auditors are frequently employed on a "by-project" or on-going
basis to conduct in-house audits of raw data, reports, tables, etc.
Extensive audits of studies, tables and data may also be conducted at the
Argus International office in connection with the preparation of INDs and
NDAs. Argus International has also provided extensive training on GLPs,
regulatory affairs, Quality Assurance as a standard of excellence and other
related topics.
Argus International
maintains an extensive registry of experienced auditors and reviewers who
can provide any Quality Assurance service required. Additionally, as
Executive Director of Science and Compliance of Charles River Laboratories
Discovery and Development Division, Dr. Christian has current information on
any regulatory changes that may occur in U.S. and international guidelines.
CORPORATE FACILITIES
AND EQUIPMENT
Location.
Argus International is located in a fully modernized historic registered
farmhouse within the Babylon Industrial Park in Horsham, PA, a suburb of
Philadelphia and is approximately 45 minutes from the Philadelphia airport
via expressway and five miles from the Pennsylvania Turnpike. Office space
(and telephone lines) that can be dedicated to the needs of a particular
client is currently available within this facility.
Computer and
Communications Equipment.
Argus International offices are equipped with state-of-the-art computer
equipment and software. High speed Hewlett Packard and Xerox laser printers
and ink jet color printers are used to produce hard copy. All computers and
PC's are equipped with Windows® operating systems and software. All
Argus International consultants and support personnel are linked to each
other and the main office via e-mail and telefax.
Security.
The Philadelphia area office of Argus International has a central-station
monitored security system and locking file cabinets.
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To Top
ABOUT THE PRESIDENT
Mildred S. Christian,
Ph.D., Fellow, ATS
is President and CEO of Argus International, Inc. Dr. Christian obtained
her Ph.D. in developmental anatomy (teratology) from Thomas Jefferson
University and has been active in industrial toxicology for more than 30
years. Since founding Argus Research Laboratories in 1979, and Argus
International in 1980, she has been personally involved in the conduct,
evaluation and submission of over 1200 developmental ("teratology"),
reproductive and general toxicology evaluations performed in-house or
under contract from protocol to final report. Dr. Christian was Executive
Director of Research of Argus Research (now a division of Charles River
Laboratories) in Horsham, PA. During the transition following the
acquisition of Argus, she served as
Executive Director of Science and Compliance of the Discovery and
Development Division of Charles River Laboratories and was responsible for
scientific integrity and regulatory compliance a corporate-wide basis. as Dr. Christian has been an
Adjunct Associate Professor in the Department of Anatomy and Developmental
Biology at Jefferson Medical College, Thomas Jefferson University,
Philadelphia, PA, since 1992 and an Adjunct Professor in the Department of
Pharmacology and Toxicology, at the University of Arkansas for Medical
Sciences, Little Rock, AR, since 1997. She is a certified Diplomate in
General Toxicology, The Academy of Toxicological Sciences (January 1, 1983;
recertified 1987, 1992, 1997 and 2002).
Through Argus
International, which provides consulting services in regulatory affairs for
industry, government agencies, law firms and professional organizations,
both in the United States and internationally, she has been involved in the
development and/or submission of over 300 agents. Dr. Christian has
developed and presented courses in Quality Assurance, multiple areas of
toxicology and regulatory affairs and position papers for chemical and
pharmaceutical companies, the U.S. FDA, the U.S. EPA, the U.S. Office of
Technology Assessment and the OECD. She also reviews data for risk
assessments and performs literature reviews for clients requiring
information on potential hazards. She has appeared as an expert witness in
several cases involving potential reproductive and developmental risks. She
recently coordinated a multinational project involving 23 different
companies that resulted in publication of a special issue of a journal.
She is an active member of
20 professional organizations, including Honorary Membership of the Society
for Quality Assurance, is a Past-President of the Teratology Society, the
American College of Toxicology the Thomas Jefferson University Alumni
Association, and the Academy of Toxicological Sciences, a founding member of
the SOT Specialty Section on Reproductive Toxicology and has served on or
chaired multiple committees of the organizations to which she belongs. She
is Founding Editor of the International Journal of the American College
of Toxicology and was its Editor-in-Chief for 10 years. She has edited
and/or contributed to several major textbooks and is author of over 110
papers and abstracts published in American and international journals.
Complete curriculum vitae available on request
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CONTACT US
| Dr. Mildred S. Christian may be
reached by mail, fax or telephone:
Mildred S. Christian, Ph.D., Fellow, ATS
Argus International, Inc.
933 Horsham Road
Horsham, PA 19044
Tel: 215-672-8867
Fax: 215-672-3619
Email: mschristian@comcast.net |
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