CMDh QUESTIONS & ANSWERS PHARMACOVIGILANCE LEGISLATION REGULATION (EU) NOAND DIRECTIVEEU Doc. Ref.: CMDh, Rev.15 January 2016

Source URL: www.hma.eu

MHRA Advice Meeting Guidance for Developers of Advanced Therapy Medicinal Products Introduction The MHRA offer various advice meetings; regulatory, scientific, pharmacovigilance, labelling and advertising. This page is i

Source URL: ct.catapult.org.uk

Pharmaceuticals and Medical Devices Safety Information No. 334 June 2016

Source URL: www.pmda.go.jp

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• Health care
• Pharmaceuticals policy
• Health
• Clinical research
• Clinical trials
• Healthcare quality
• Pharmacovigilance
• Pharmacy
• Medical prescription
• Pharmaceutical industry in China
• Pharmaceutical industry

Sustainability at AstraZeneca Responsible research Our approach

Source URL: www.astrazeneca.com

• Medical research
• Health
• Clinical research
• Pharmaceutical industry
• Clinical pharmacology
• Pharmacy
• Clinical trial
• Pharmacovigilance
• European Federation of Pharmaceutical Industries and Associations
• Animal testing
• Animal welfare
• Medicine

B.08 GUIMA Transfer national requirements AT BE CZ DE(BVL, PEI) EE ES FI FR IE IS IT LT LV NL PL RO SE SK SI UKEMA-CMDv

Source URL: www.hma.eu

• Pharmaceuticals policy
• Health care
• Health
• Pharmaceutical industry
• Medical research
• Healthcare quality
• European Medicines Agency
• European Union
• Qualified Person Responsible For Pharmacovigilance
• Marketing authorization
• Summary of Product Characteristics
• Pharmacovigilance

Managing patients’ safety: Need for PharmacoVigilance Dr. Hanmant Barkate, MBBS, MD Associate Vice-President& Head Medical, Clinical & Regulatory affairs Intas Pharmaceuticals Ltd., Ahmedabad

Source URL: www.iimahd.ernet.in

• Medical research
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• Health
• Clinical research
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• Drug safety
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• Adverse drug reaction
• Nonsteroidal anti-inflammatory drug
• Yellow Card Scheme

EFPIA Annual Report 2015 @EFPIA Introduction

Source URL: www.efpia.eu

• Health care
• Health
• Business
• Pharmaceutical industry
• European Federation of Pharmaceutical Industries and Associations
• Pharmaceuticals policy
• Clinical trials
• Innovative Medicines Initiative
• Pharmaceutical Research and Manufacturers of America
• Pharmacovigilance
• Novartis
• EuropaBio

CMDv GUIPartial MAH transferEMA-CMDv

Source URL: www.hma.eu

• Pharmaceuticals policy
• Health care
• Health
• Healthcare quality
• Pharmaceutical industry
• Medical research
• Drug safety
• Agencies of the European Union
• Qualified Person for Pharmacovigilance
• European Medicines Agency
• Pharmacovigilance
• Marketing authorization

The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia has prepared the unofficial consolidated text for the Medicinal Products Act which includes:  Medicinal Products Act (Official Gazette

Source URL: www.jazmp.si

• Pharmaceuticals policy
• Health
• Medical research
• Clinical Trials Directive
• Directive 2001/83/EC
• Good laboratory practice
• Marketing authorization
• Good Clinical Practice Directive
• European Pharmacopoeia
• Biopharmaceutical
• Pharmacovigilance
• European Medicines Agency

ANNEX 2 AFUnexpected Adverse Event Summary Report Principal Investigator: ………………………………………………………………………….

Source URL: www.health.gov.bt

• Medical research
• Clinical research
• Medicine
• Health care
• Pharmaceutical industry
• Clinical pharmacology
• Medical terminology
• Adverse event
• Adverse effect
• Pharmacovigilance