Guideline on the quality of Transdermal Patches

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

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

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

GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A …

10.1 Examination of design dossier 20 10.2 Evaluation as part of the quality system procedure 23 10.3 Notified body specific procedure and expertise 24 ... Harmonisation Task Force (GHTF) international regulatory guidance document on clinical evaluation (SG5/N2R8:2007).

  Design, Guidance, Dossiers, Examination, Design dossier

Guidance on Design-Dossier Examination and Report …

Guidance on Design-Dossier Examination and Report Content 1 Background The objective of this document is to give guidance to: – the Notified Bodies (NB) of the type of content expected of the Notified Body Design Dossier Reports of Medical Device manufacturers to ensure manufacturer’s confor-mance to the relevant Directive

  Design, Report, Guidance, Dossiers, Content, Examination, Guidance on design dossier examination and report, Design dossier, Guidance on design dossier examination and report content

Guidance for manufacturers and Notified Bodies on ...

Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System ... Document assessment related to the product or complete re-assessment of the design dossier or the type examination dossier Document assessment related to the quality system, special audit or complete re- ...

  Design, Guidance, Dossiers, Examination, Notified, Manufacturers, Bodies, Guidance for manufacturers and notified bodies on, Design dossier, Examination dossier

Guidance on Notified Body‘s Tasks of Technical ...

[4] NBOG BPG 2009-1 Guidance on Design-Dossier Examination and Report Content [5] EN ISO 15225 : 2000/A1 : 2004 Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regula-tory data exchange [6] NBOG BPG 2009-3 NBOG Guidance …

  Design, Guidance, Dossiers, Examination, Guidance on design dossier examination and

Reporting of design changes and changes of the quality system

and documenting any changes to the device design/type (including software) and/or quality system as either “substantial“ or not substantial. As set out in the MDD changes to the design of a device are relevant to conformity assessment under annex II, 4 (design examination) and annex III (type examination).

  Design, Examination, Design examination

Medical Device Directive (MDD)

• Summary of history of design changes is required vs. just the current design. • Notified Body must approve 100% of Significant Changes Prior to Implementation. • Notified Body will Scrutinize Each Document more Carefully. – “…the typical review time devoted to a design dossier is “at least double” the time spent on the

  Devices, Design, Medical, Dossiers, Directive, Medical device directive, Design dossier

Guidance on the procedural aspects for the consultation to ...

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified ... and shall enable conformity with the design -related requirements of this Regulation to be assessed, in 84. ... approved through the EU type -examination certificate or its suitability in relation to a medicinal . 138.

  Design, Guidance, Examination

Reporting Changes to the Notified Body - BSI Group

design must receive further approval… wherever the change could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product. Annex III . The applicant shall inform the notified body which issued the EC type examination certificate of any modification made to the approved product.

  Design, Change, Reporting, Examination, Reporting changes to

Annex 7 - WHO

Annex 7 133 10.3.3 Dissolution profile comparison for biowaivers based on dose- proportionality of formulations 177 10.4 In vitro equivalence testing for non-oral dosage forms 177 10.5 In vitro equivalence testing for scale-up and post-approval changes 180 References 180 Appendix 1 Recommendations for conducting and assessing comparative

DNVGL-ST-E273 2.7-3 Portable offshore units

Standard, DNVGL-ST-E273 – Edition April 2016 Page 3 DNV GL AS CHANGES – CURRENT Changes – current General This document supersedes DNV Standard for Certification 2.7-3, …