European Medicines Agency

© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline

  Guidelines, European, Agency, Medicine, Harmonised, European medicines agency, Ich harmonised

Q12 Step 2b Technical and regulatory …

ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36

  Product, Management, Lifecycle, Product lifecycle management

Guideline on good pharmacovigilance practices …

9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25

  Good, Practices

Guideline on good pharmacovigilance practices …

Guideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

Guideline for good clinical practice E6(R2)

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification

  Good, Practices, Clinical, Good clinical practice

Guideline for good clinical practice E6(R2)

Guideline 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

  Guidelines, Good, Practices, Clinical, Good clinical practice e6

Guideline on good pharmacovigilance practices …

harmful 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

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

products1/traditional herbal medicinal products

There 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

  Product, Medicinal, Traditional, Herbal, Products1 traditional herbal medicinal products, Products1

Q7 Q&A - good manufacturing practice for active ...

ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37

  Good, Practices, Pharmaceutical, Manufacturing, Active, Ingredients, Good manufacturing practice for active, Good manufacturing practice for active pharmaceutical ingredients

IS Standards, Guidelines and Procedures for Auditing and ...

Procedures for Auditing and Control Professionals ... without the prior written authorisation of ISACA. Reproduction of all or portions of this publication is solely permitted for academic, internal and non-commercial use, and must include full attribution as follows: " 2009

  Procedures, Authorisation, And procedures

European Medicines Agency pre-authorisation procedural ...

authorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication. The EMA emphasises the importance of pre-submission meetings between applicants and the EMA/(Co-) Rapporteur. Pre-submission meetings (which should take place approximately 7 ...

  Procedures, Authorisation, Authorisation procedures

SAFE TRANSPORTATION OF CHILDREN

The written authorisation given by a parent or other person named in the child’s enrolment record must now also state: • – e.g. a government department that provides an if the authorisation is for a regular outing, a description of when the child is to be taken on the regular outings • if the authorisation is for an excursion that is not a

  Safe, Children, Transportation, Authorisation, Safe transportation of children

Fostering Services National Minimum Standards

Fostering Services: National Minimum . Standards. Fostering Services NMS cover.indd 1 02/03/2011 16:39:55

  Standards, National, Minimum, National minimum standards, National minimum

Statement of Cash Flows

AASB 107 6 STANDARD Cash equivalents are short-term, highly liquid investments that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value. Cash flows are inflows and outflows of cash and cash equivalents. Operating activities are the principal revenue-producing activities of the entity and other activities

Kindergarten Funding Guide

6 | kindergarten funding guide The Kindergarten Funding Guide (the guide) is designed to assist service providers that: • provide kindergarten programs in Victoria • currently receive kindergarten funding from the Department of Education and Training (the Department) or wish to receive