Understand European GMPs and the Role of the QP

7 - 8 June 2011, Washington D.C. Metro Area, USA.
With optional Post-Conference Sessions on June 9, 2011.
Over the past few years the role and duties of the Qualified Person keep increasing in significance and scope. Being the key person in the quality function of a pharmaceutical company, the QP has to consider many issues to fulfil the responsibilities and to comply with the European legislation.

This Conference is designed by QPs and international Experts as a forum with focus on sharing information and experience and on discussing the critical areas of European GMPs and the QP's daily work.

The Conference has been designed for non-European QA and QCU personnel, upper management functions and authority representatives who want to be informed about the latest development regarding European GMPs and the duties and responsibilities of Qualified Persons.

Speakers:

  • Richard M. Bonner, Qualified Person, Formerly with Eli Lilly and Company Ltd., UK
  • Dr Christopher Burgess, Qualified Person, Burgess Analytical Consultancy, UK
  • Dr Dimitrios Catsoulacos, European Medicines Agency, EMA
  • Dr Bernd Renger, Qualified Person, Chairman, European QP Association
  • Dr Janice Soreth, FDA, Office of International Programs at EMA
  • Martine Tratsaert, Qualified Person, Johnson & Johnson, Belgium
  • Mark Tucker, Ph.D., Genentech Inc./Roche Group, USA

Highlights
Understand European GMPs

  • ƒ The European Pharmaceutical Legislation
  • ƒƒ Import/ Export, CEPs and GMP Certificates
  • ƒƒ EU Product Quality Review Requirements versus US Annual Report Requirements

Understand the Role of the QP

    ƒƒ
  • The Legal and Professional Duties of the Qualified Person
  • ƒ EU Inspections in the U.S. and the Involvement of the QP
  • ƒƒ The EU Discretion Paper and the Release of Batches by the QP
  • ƒƒ The Role of the QP in Contract Manufacturing
  • ƒƒ The role of the QP in the Supply Chain and Supplier Qualification
  • ƒƒ The US Quality Unit versus the EU QP

The view of FDA and EMA
With optional Post-Conference Sessions on June 9, 2011

  • ƒƒ Session 1: Case studies: Certification by a QP and Batch Release
  • ƒƒ Session 2: Clinical Trial Supplies: IMP Handling in Europe and the Role of the QP

For further information and registration, please visit:
http://www.gmp-compliance.org/qpag_forum_5.html

Most Popular Now

OPKO and Pfizer announce positive Phase 3 top-line…

OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with g...

Amgen recommends rejection of 'mini-tender' offer …

Amgen (NASDAQ:AMGN) today announced that it has been notified of an unsolicited "mini-tender" offer dated Oct. 11, 2019, made by TRC Capital Corporation, a private Canadi...

Researchers find new signaling systems in human ce…

The human cell has a wide variety of receptors on its surface that many molecules and therapeutic drugs can bind to in order to activate signals inside the cell to regula...

Rare diseases: Over 300 million patients affected …

Rare diseases represent a global problem. Until now, the lack of data made it difficult to estimate their prevalence. Created and coordinated by Inserm, the Orphanet data...

Bed time is the best time to take blood pressure m…

People with high blood pressure who take all their anti-hypertensive medication in one go at bedtime have better controlled blood pressure and a significantly lower risk ...

One avocado a day helps lower 'bad' cholesterol fo…

Move over, apples - new research from Penn State suggests that eating one avocado a day may help keep "bad cholesterol" at bay. According to the researchers, bad choleste...

Rare diseases: Over 300 million patients affected …

Rare diseases represent a global problem. Until now, the lack of data made it difficult to estimate their prevalence. Created and coordinated by Inserm, the Orphanet data...

Boehringer Ingelheim advances first pan-KRAS inhib…

Boehringer Ingelheim presented promising preclinical data from its pan-KRAS program including the novel, oral inhibitor BI 1701963 at the AACR-NCI-EORTC International Con...

Synthetic phages with programmable specificity

Bacteriophages ("phages" for short) are viruses that infect bacteria. Phages are highly host-specific and will typically only infect and kill an individual species or eve...

Cannabis could help alleviate depression and suici…

Cannabis may be helping Canadians cope with the effects of post-traumatic stress disorder (PTSD), new research suggests. In an analysis of health survey data collected by...

AstraZeneca divests rights to Seroquel and Seroque…

AstraZeneca has agreed the sale and licence of the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended rel...

Attacking metastatic breast cancer with sound

Drugs can be safely delivered to cancerous lymph nodes via the lymphatic system and then released inside the nodes using sound waves. Tohoku University researchers tested...