Navigation Links
Pharmaceutical Quality Metrics Conference Shapes PDA Metrics Agenda
Date:12/19/2013

BETHESDA, Md., Dec. 19, 2013 /PRNewswire-USNewswire/ -- The Parenteral Drug Association, Inc. (PDA) held a well-attended and received, interactive 2013 PDA Pharmaceutical Quality Metrics Conference, Dec. 9-10 in Bethesda, Md.

(Logo: http://photos.prnewswire.com/prnh/20130226/DC66667LOGO)

Over 300 industry experts on drug product quality and manufacturing assembled to participate in breakout discussions and select the most important and useful quality metrics. The interactive sessions were set up to assist a PDA task force draft a points to consider report on pharmaceutical quality metrics, which PDA intends to submit to the U.S. FDA in December.

A large number of CDER officials also attended the meeting, including Director Janet Woodcock.

Woodcock took the podium in the closing session and thanked PDA for holding the workshop.

"This is really important. We are having an ongoing dialogue about this issue of metrics. I was able to come and listen to the report-out from the polls and breakout sessions. I was very intrigued by both the engagement and what people actually said about what is going on. It gave me a lot of hope that we can really make this happen," she said.

In closing the conference, PDA President Richard Johnson assured participants that the feedback received greatly helped the PDA task force refine its points to consider report, which will be sent to the U.S. FDA before the end of 2013.

"Whatever the team was thinking before the meeting, I can assure you it is different today....If it was easy, we wouldn't need a meeting."

Moving forward, Johnson pledged that PDA "will invite and try to work with other organizations in the coming year to harmonize specifically some definitions of some of these metrics so as we move forward at least that is not a barrier."

"We already had a discussion within PDA to do a blinded survey of these draft metrics that we are going to pull together so that companies can self-report and we can share the results in a blinded way with companies --a beta test to see if we identified things that are going to be meaningful to differentiate."

Johnson noted PDA's readiness to conduct a pilot program to identify issues and challenges that would need to be addressed prior to the rollout of an official U.S. FDA metrics program. 

The data from the survey and the pilot will be used to help assess the robustness of the proposed definitions, the ease and availability in which the data is collected, and the knowledge and value gained from the data reported.

Finally, Johnson indicated that PDA is considering a follow-up Pharmaceutical Quality Metrics Conference in 2014.

About PDA

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its nearly 10,000 members worldwide. PDA's Annual Meeting will be held April 7-9, 2014 in San Antonio, Texas. For information, visit www.pda.org and follow PDA on LinkedIn.

Press Contact

Amelia Townsend
Director of Marketing Services, Parenteral Drug Association® (PDA)
(301)656-5900 ext. 153
E-mail townsend@pda.org


'/>"/>
SOURCE Parenteral Drug Association
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
2. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
3. Pharmaceutical Industry Service Company Awarded The UKs Most Prestigious Business Accolade in Recognition of Outstanding Achievement in International Trade
4. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
5. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
6. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
7. Thomson Reuters Launches New Mobile Oncology Decision Support Solution for R&D Pharmaceutical Leaders
8. Amgen to Acquire Mustafa Nevzat, a Leading Privately Held Turkish Pharmaceutical Company
9. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
10. Icahn Issues Statement Regarding Amylin Pharmaceuticals
11. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
Breaking Medicine Technology:
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of ... recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at Work ... Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
Breaking Medicine News(10 mins):