FOR RELEASE October 15, 2006
(Click HERE to download this release)
Contact:
Michelle Herrera Foster, Ph.D.
CTD Quality Consulting
978-356-0872
info@ctdquality.com
Wiley Publishing Selects Authors for Pharmaceutical Textbook on
Chemistry, Manufacturing, and Controls in New Drug Applications
Book Includes Guides to Streamlining Regulatory Processes
Baltimore, MD – RAPS – CTD Quality Consulting
is pleased to announce at the annual Regulatory Affairs Professional
Society (RAPS)
Conference that Dr. Mukund Chorghade and Dr. Michelle Herrera Foster
have been contracted by John Wiley and Sons Publishing to write a text
book entitled “Chemistry, Manufacturing, and Controls in New Drug
Applications”. Dr. Chorghade has also been contracted to write
the text book “Good Manufacturing and Good Laboratory Practices
in Pharmaceuticals.” These text books will benefit scientists and
regulatory affairs professionals in:
-
Preparation of submission-ready chemistry, manufacturing, and controls
(CMC) documents in the Common Technical Document (CTD) format and
-
Streamlining the IND (investigational new drug application) and NDA
(new drug application) process with more rapid efficient preparation
and smoother/faster
agency review.
The authors have been selected based on their combined expertise in
teaching and consulting on CMC documentation for regulatory submissions
in the pharmaceutical industry. According to Wiley, “the real value of
the proposed text (for CMC submissions) will be in providing an insightful
and well-illustrated practical discourse on the NDA process.” It
is expected the two books will be published in early 2008.
About CTD Quality Consulting
CTD Quality Consulting (www.ctdquality.com) provides training, templates,
expert authoring, review, and gap analysis of CMC documents, and
preparation of the CTD module 3 Quality and the Quality Overall
Summary for investigational
and marketing applications. Michelle Herrera Foster, Ph.D. Chemistry,
Principal, has more than 20 years experience in the pharmaceutical
industry, with 17 years experience in preparing regulatory submissions
for drugs and biologics. She presents at RAPS and Drug Information
Association meetings and will be hosting the Roundtable session on
CMC submissions at the RAPS annual meeting 10/18/06.
Dr. Mukund Chorghade, Chorghade Enterprises, provides consultations
and training to major pharmaceutical companies on collaborations with
worldwide academic, government and industrial laboratories, European
technology based companies, process re-engineering, and project management
of technology transfer and establishing strategic partnerships. Dr. Chorghade
has been the recipient of three "Scientist of the Year Awards",
is a featured speaker in several national and international symposia,
and is on the Board of Directors of the Northeastern Section of the American
Chemical Society. Drs. Chorghade and Foster teach courses at the Massachusetts
College of Pharmacy.
About John Wiley & Sons, Inc.
John Wiley & Sons, Inc. enjoys a global reputation among the worldwide
community or scholars. It enjoys sterling brand recognition as a purveyor
of scientific and technical encyclopedias and text books and relevant
educational materials for undergraduate and graduate students and mid-career
professionals.
|
