ANHANG I ZUSAMMENFASSUNG DER MERKMALE …

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

Entyvio (vedolizumab) Injectable Aetna …

Entyvio® (vedolizumab) Injectable Medication Precertification Request Aetna Precertification Notification 503 Sunport Lane, Orlando, FL 32809 Phone: 1-866-503-0857 FAX: 1-888-267-3277

  Aetna, Vedolizumab

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

6 Vedolizumab has been studied in adult ulcerative colitis and Crohn’s disease patients with concomitant administration of corticosteroids, immunomodulators (azathioprine, 6 …

  Product, Summary, Characteristics, Summary of product characteristics, Vedolizumab

Biologics Fact Sheet - 01 - Colitis | IBD | Crohn’s ...

•Cancer Risk. Anti-TNF medications have been associated with a small, but measurable, increase in the incidence of lymphoma, an uncommon cancer.

  Fact, Sheet, Biologics, Biologics fact sheet 01

ADA17002 09-17 (file received 9.21.2017) front

Specimens should be labeled with 2 identifiers and d a t e of c ollection. E x amples of a cc eptable identifiers includ e, but a r e not limi t ed t o, p