Pptimized research and safer medicines. Pietrek Associates is a consultancy group specialized in clinical development strategy, drug safety, risk management and quality management throughout the life-cycle of medicinal products.
http://www.pietrekassociates.com/
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Pietrek Associates GmbH
Christina Vogt
Rosenb●●●●●●str. 8
Wei●●●eim , 69469
DE
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Pietrek Associates GmbH
Christina Vogt
Rosenb●●●●●●str. 8
Wei●●●eim , 69469
DE
View this contact
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Pietrek Associates - Pietrek Associates GmbH | pietrekassociates.com Reviews
https://pietrekassociates.com
Pptimized research and safer medicines. Pietrek Associates is a consultancy group specialized in clinical development strategy, drug safety, risk management and quality management throughout the life-cycle of medicinal products.
pietrekassociates.com
Regulatory References
http://www.pietrekassociates.com/regulatory-references
Here is an overview of selected key legislation and regulatory guidelines (EU, USA and International level) relevant generally to pharmacovigilance and drug safety that need to be considered during drug development and marketing (non-exclusive):. Regulations: directly applicable across the EU. Regulation (EC) No. 726/2004. Amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No. 726/2004. Regulation (EU) No. 1027/2012. Implementing Regulation (EU) No. 520/2012.
About Us
http://www.pietrekassociates.com/about-us
Monika Pietrek, MD, PhD, MSc. Over 20 years experience in clinical research and safety / risk management in both pharmaceutical and CRO industries as well as in a regulatory agency. Broad range of therapeutic expertise, e.g. cardio-vascular disorders, CNS, gastroenterology, immunology, metabolic disorders, and oncology. Special interests include: clinical development strategies, life-cycle risk management, and pharmaco-epidemiology. Rosalind Coulson, MSc, FRPharmS. Christina Vogt, M.A. Melanie Weber, MSc.
Services
http://www.pietrekassociates.com/services
Pietrek Associates consultants provide their services globally: Since 2009 they have worked in over 70 countries in Africa, Asia, Australia, Europe and North and South America. Services are applicable to clinical development and the post-authorization period. Systematic literature review of targeted indication. Definition of unmet medical need. Design of natural history of disease studies. Identification of data sources for observational studies. Review of study options and appraisal of feasibility.
News & Events
http://www.pietrekassociates.com/news-events
Most recent revisions to GVP Modules. On 08-Dec-2015 the European Medicines Agency (EMA) published GVP Module XVI Addendum I - Educational Materials, which became effective on 16-Dec-2015. This was the last missing GVP Module as the topics originally planned for module numbers XI, XII, XIII and XIV have been addressed by other guidance documents. No additional GVP modules are planned. Modules VIII, VIII Addendum 1, and XV are currently under revision. Workshop on What are the drug risks of research?
Scientific Communications
http://www.pietrekassociates.com/scientific-communications
Pietrek Associates share an in-depth knowledge in the fields of clinical development, regulatory affairs, as well as safety and risk management. The sample list of previous presentations and publications provided below is an example of the cumulative expertise of our staff. Highlights 2013: EU PV Legislation Implementation. Pietrek M., Coulson R. and Huisman, W. Has the Emphasis on Quality Systems Changed Pharmacovigilance? Global Forum. August 2013; 5 (4) 18-20. Highlights 2012: New EU PV Legislation.
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PV Consultancies | Perspektivo
http://www.perspektivo.nl/dpvo/perspektivo/pv-consultancies
Skip to main content. Supporting your perspective on pharmacovigilance. On Thu, 07/01/2010 - 15:24. Vigilex B.V. (Operational Headquarters). Tel: 31 10 244 73 99. Http:/ www.vigilex.com/. Read more about Vigilex. On Thu, 07/01/2010 - 12:57. Caerus Consulting Pty. Ltd. Http:/ www.caerus.net.au/. 28th Floor, Tower 2, The Enterprise Center. 6766 Ayala Ave corner. Paseo de Roxas Makati 1226. Read more about Caerus. On Mon, 06/28/2010 - 17:20. 2 Old Bath Road. Http:/ www.pharmatracks.com/. Tel 1 919 401 8003.
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Pietrek, Detern
Tel: 0 49 57 / 3 86. Lotto / Toto, Schulartikel. Reinigung und Wäscherei, Annahmestelle. Alles was Jümme braucht.
Pietrek Monreal's blog
Friday, September 18, 2009. Advertisement. Overview. Date of Birth: 21 January 1959, Osaka, Japan more. STARmeter: Down 4% in popularity this week. See rank and trends on IMDbPro. Alternate Names: Masaki Kyomoto (京æ¬æ"¿æ¨¹, Kyoumoto Masaki) is a Japanese actor, singer, and guitarist. He is currently represented by Office Zan. January 21, 1959 â") is a Japanese actor, singer, tarento, and guitarist from Suita, Osaka Prefecture. Masaki Kyomoto Mini Diary. Main Diary in Members Site. Coming Soon! Edit] ...
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Folien Monheim: Startseite
Sie sind hier: Startseite. Die Folien GmbH Monheim ist nach der europaweit anerkannten Norm DIN EN 15593/2008: Hygienemanagement bei der Herstellung von Lebensmittelverpackungen zertifiziert. Wir verarbeiten mit hochmodernen Wickelautomaten sowohl PE- als auch PVC- Frischhaltefolien sowie Aluminiumfolie zu Refills, Cutterboxen, Perfo-Rollen und Großrollen bis zu einer Breite von 1.100 mm. Folien GmbH Monheim 2013.
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Pietrek Associates - Pietrek Associates GmbH
Epidemiology Reviews and NIS Design. Vendor Selection and Monitoring. Optimized research and safer medicines. Epidemiology Reviews and NIS Design. Vendor Selection and Monitoring. Welcome to Pietrek Associates. Founded in 2009, Pietrek Associates is proud to be a leading, independently owned consultancy in a sector increasingly p. Pietrek Associates consultants provide their services globally. Welcome to Pietrek Associates. Founded in 2009, Pietrek Associates is proud to be. Benefit / Risk Evaluations.
PietrekcSFGame
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Monday – Thursday. 9am – 12pm & 3pm – 6pm. 9am – 12pm. Super Gentle and Safe for All Ages. Over 2,000 Patients Treated. Toddler to Elderly Care. Accident and Injury Care. I’m Dr. James Pietrek. Or learn more about me here. I look forward to helping you get out of pain! Let me help you be your best! Learn how NUCCA can help you. NUCCA & Insurance FAQs. Upper Back Part 1. Upper Back Part 2. Upper Back Part 3. Iliotibial Band (IT Band). Glutes with Tennis Ball. How Can I Hold My Adjustments Better? 16959 Be...
pietreland
Le immagini presenti nel sito sono di esclusiva proprieta' dell'autore . Tutti i diritti sono riservati e registrati. Web master Gianni Crepaldi - ultimo aggiornamento 11 Giugno 2015.
