About | Free Trial

Last Update

2011-12-01T00:00:00.000Z

This profile was last updated on .

Is this you? Claim your profile.

Wrong Janice Soreth?

Dr. Janice Soreth M.

Chief Executive Officer

Hovione LLC

HQ Phone: (609) 918-2600

Get ZoomInfo Grow

+ Get 10 Free Contacts a Month

I agree to the Terms of Service and Privacy Policy. I understand that I will receive a subscription to ZoomInfo Community Edition at no charge in exchange for downloading and installing the ZoomInfo Contact Contributor utility which, among other features, involves sharing my business contacts as well as headers and signature blocks from emails that I receive.

Hovione LLC

40 Lake Drive

East Windsor, New Jersey 08520

United States

Company Description

Hovione is an international company with over 50 years' experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the USA, China, Ireland, and Portugal, an ... more

Find other employees at this company (653)

Background Information

Employment History

European Commission

MarketKey Ltd

Windhover Information Inc

Department of Health and Human Services

Supervisory Medical Officer

HHS

Director of the Division of Anti-Infective and Ophthalmology Products

Center for Drug Evaluation and Research

Affiliations

Liaison
European Medicines Agency

Liaison
EMA

Board of Trustees Member
Gordon Research Conferences incorporated

Education

B.A.

Temple University

M.D. degree

University of Pittsburgh

Web References (118 Total References)


Both Guy Villax, CEO of ...

www.specchemonline.com [cached]

Both Guy Villax, CEO of Hovione, in a press conference and Janice Soreth, deputy director of the London office of the US Federal Drugs Administration (FDA), who was the keynote speaker at the EFCG Dinner, which was also held during CPhI, discussed GDUFA at length.

...
At the end of the five-year period, Soreth said, the FDA will be acting on 90% of complete electronic ANDAs within ten months, as opposed to an average of 31 at present. It will also act on 90% of all the ANDAs and PAS pending on 1 October 2012. Meanwhile, parity should be achieved between US and foreign API and FDF sites, with both receiving risk-adjusted biennial cGMP surveillance inspections.
Other key performance metrics will include the use of complete review-response letters, completeness assessments for DMFs that are intended to be referenced by the ANDA sponsors and division-level deficiency review and first cycle meetings for ANDAs and DMFs. The FDA, Soreth said, will also develop regulatory guidance for industry and take initiatives to enhance post-marketing safety.
"GDUFA is a welcome paradigm shift for all generic industry participants, regardless of size or geographic location, as well as consumers, with predictable review times and certainty of inspection for all facilities," she said.
...
Soreth updated the EFCG Dinner on the FDA's moves to better inspection abroad
...
During her presentation, Soreth also recognised that FDA's record of inspecting abroad is inadequate and her address to the EFCG Dinner detailed some of the ways it has been seeking to remedy this in recent years. This summer, she noted, a 24-month pilot programme of joint inspections with the European Medicines Agency (EMA) and Australia's Therapeutic Goods Administration concluded successfully.


The Walpole Lectures : MarketKey

www.marketkey.co.uk [cached]

Janice M. Soreth

...
Janice M. Soreth
Deputy Director, FDA Europe Office
Janice Soreth is Deputy Director of the US FDA's Europe Office, coordinating FDA activities in Europe for medical products (human and veterinary drugs, biologics, and devices). She is seconded to the European Medicines Agency and resides in London. She directed FDA's Division of Anti-Infectives and Ophthalmology from 2000-2007 and served as a general internist in the US Public Health Service.


The Walpole Lectures : MarketKey

www.marketkey.co.uk [cached]

Janice M. Soreth

...
Janice M. Soreth
Deputy Director, FDA Europe Office
Janice Soreth is Deputy Director of the US FDA's Europe Office, coordinating FDA activities in Europe for medical products (human and veterinary drugs, biologics, and devices). She is seconded to the European Medicines Agency and resides in London. She directed FDA's Division of Anti-Infectives and Ophthalmology from 2000-2007 and served as a general internist in the US Public Health Service.


PSA 2011 Biographies

www.windhover.com [cached]

Linda Heitzman | Navjot Singh, PhD | Jose-Carlos Gutiérrez-Ramos | Christopher Haskell, PhD | Kathleen Mullinix | Ajay Dhankhar, PhD | Bruce Booth, DPhil | Paul Laikind, PhD | Mahmood Ladha | Marcus Wilson | George Scangos | Ben Bonifant | Robert Hershberg, MD, PhD | Fred Paster | Milayna Subar, MD | Jerry McMahon, PhD | David M. Reese, MD | David DeMarco | Dennis Urbaniak | Kim Park | David Holveck | Lamberto Andreotti | Adele Gulfo | Wael Fayad | David Quigley | Riad el Dada | Gillian Woollett, DPhil (moderator) | Diem Nguyen, PhD | Michael Kamarck | James Roach, MD | Janice M. Soreth, MD | Jacquelyn Nicholson | Håkan Björklund, PhD | Ian Tomlinson | Kristin Peck | Tom Heyman | Jeremy M. Levin | Barbara Yanni | Iain D. Miller, Ph.D. | Nic Dracopoli, PhD | Risa Stack, PhD | Michael Pellini

...
Janice M. Soreth, MD - Back to Schedule Deputy Director, FDA Europe Office Liaison to EMA
Janice Soreth grew up in Philadelphia, Pennsylvania, and obtained her B.A. from Temple University in 1978, graduating summa cum laude with honors in biology. She went to work as a research technician at the Wistar Institute in the rabies program of Hilary Koprowski and Tad Wiktor. In 1983, Janice received the M.D. degree from the University of Pittsburgh, and following training in internal medicine at the George Washington University Medical Center, she practiced in the US Public Health Service on the island of Pohnpei, Federated States of Micronesia. She then accompanied her family to Ulan Bator, for the opening of the first US diplomatic mission to Mongolia in 1988. Upon returning to the United States, she took up the practice of medicine with Kaiser Permanente in suburban Washington, D.C. Dr. Soreth joined the US Food & Drug Administration in 1990 as a Medical Officer. She directed the Division of Anti-Infective and Ophthalmology Products from 2000 to 2007. She has experience as well in the Office of Vaccines and the Office of Combination Products. In December 2008, Dr. Soreth was selected to open FDA's first Office in London. She serves in a liaison capacity, seconded to the European Medicines Agency on Canary Wharf, to help coordinate FDA activities throughout Europe for medical products- human and veterinary drugs, biologics, and devices. She resides in London.


PSA 2011 Biographies

www.windhoverinfo.com [cached]

Linda Heitzman | Navjot Singh, PhD | Jose-Carlos Gutiérrez-Ramos | Christopher Haskell, PhD | Kathleen Mullinix | Ajay Dhankhar, PhD | Bruce Booth, DPhil | Paul Laikind, PhD | Mahmood Ladha | Marcus Wilson | George Scangos | Ben Bonifant | Robert Hershberg, MD, PhD | Fred Paster | Milayna Subar, MD | Jerry McMahon, PhD | David M. Reese, MD | David DeMarco | Dennis Urbaniak | Kim Park | David Holveck | Lamberto Andreotti | Adele Gulfo | Wael Fayad | David Quigley | Riad el Dada | Gillian Woollett, DPhil (moderator) | Diem Nguyen, PhD | Michael Kamarck | James Roach, MD | Janice M. Soreth, MD | Jacquelyn Nicholson | Håkan Björklund, PhD | Ian Tomlinson | Kristin Peck | Tom Heyman | Jeremy M. Levin | Barbara Yanni | Iain D. Miller, Ph.D. | Nic Dracopoli, PhD | Risa Stack, PhD | Michael Pellini

...
Janice M. Soreth, MD - Back to Schedule Deputy Director, FDA Europe Office Liaison to EMA
Janice Soreth grew up in Philadelphia, Pennsylvania, and obtained her B.A. from Temple University in 1978, graduating summa cum laude with honors in biology. She went to work as a research technician at the Wistar Institute in the rabies program of Hilary Koprowski and Tad Wiktor. In 1983, Janice received the M.D. degree from the University of Pittsburgh, and following training in internal medicine at the George Washington University Medical Center, she practiced in the US Public Health Service on the island of Pohnpei, Federated States of Micronesia. She then accompanied her family to Ulan Bator, for the opening of the first US diplomatic mission to Mongolia in 1988. Upon returning to the United States, she took up the practice of medicine with Kaiser Permanente in suburban Washington, D.C. Dr. Soreth joined the US Food & Drug Administration in 1990 as a Medical Officer. She directed the Division of Anti-Infective and Ophthalmology Products from 2000 to 2007. She has experience as well in the Office of Vaccines and the Office of Combination Products. In December 2008, Dr. Soreth was selected to open FDA's first Office in London. She serves in a liaison capacity, seconded to the European Medicines Agency on Canary Wharf, to help coordinate FDA activities throughout Europe for medical products- human and veterinary drugs, biologics, and devices. She resides in London.

Similar Profiles

Other People with this Name

Other people with the name Soreth

Jane Soreth
CONTACT Cape-Atlantic

Carmen Soreth
Monmouth Truck Equipment LLC

Joe Soreth
Furino & Sons Inc

Michele Soreth
AtlantiCare Foundation Inc

John Soreth
Zep Inc.

Browse ZoomInfo's Business Contact Directory by City

Browse ZoomInfo's
Business People Directory

Browse ZoomInfo's
Advanced Company Directory