European Medicines Agency guidance for applicants …
European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance EMA/4260/2001 Page 3/23 . Instructions for users
Download European Medicines Agency guidance for applicants …
Information
Domain:
Source:
Link to this page:
Documents from same domain
Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
Guideline on good pharmacovigilance practices …
www.ema.europa.eu9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25
Guideline on good pharmacovigilance practices …
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November
Guideline on good pharmacovigilance practices …
www.ema.europa.euharmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product
European Medicines Agency
www.ema.europa.eu© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline
products1/traditional herbal medicinal products
www.ema.europa.euThere is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already
Q7 Q&A - good manufacturing practice for active ...
www.ema.europa.euICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37
Related documents
CONSUMER ASSISTANCE PROGRAM
www.bar.ca.govCALIFORNIA DEPARTMENT OF CONSUMER AFFAIRS Questions? Please call 866.272.9642 or visit www.smogcheck.ca.gov. Page 1 of 3 CAP/ER (Rev. 03/18) CONSUMER ASSISTANCE PROGRAM
Allianz Global Assistance Online Travel Protector …
www.magroup-online.com1 Online Travel Protector Policy Wording v1.0 Effective 1st August 2016 Allianz Global Assistance – Online Travel Protector TABLE OF CONTENTS BENEFITS Pg 1 – 13
Screening and Assessment instruments May 2008 …
www.nectac.orgIn recent years, there has been a growing emphasis on the mental health and social and behavioral developmental needs of very young children. In response,
NEW JERSEY HOSPITAL CARE PAYMENT …
www.nj.govNew Jersey State Department of Health Health Care for the Uninsured Program NEW JERSEY HOSPITAL CARE PAYMENT ASSISTANCE FACT SHEET Kim Guadagno
THE DAC LIST OF ODA RECIPIENTS - OECD.org - …
www.oecd.orgwww.oecd.org/dac/stats/daclist THE DAC LIST OF ODA RECIPIENTS NATURE AND PURPOSE OF THE LIST The DAC1 List of ODA Recipients shows the countries and territories eligible to receive official development assistance (ODA).
Arkansas Nursing Assistance Candidate …
www.prometric.com2 Rev. 08012017 Please have your current employer complete this section. Current or previous employer *Name of Long Term Care Facility or Agency Where Employed