Ensuring the gap between science and practice is filled safely - MHRA
|
|
- Beatrix Lewis
- 6 years ago
- Views:
Transcription
1 Safeguarding public health Ensuring the gap between science and practice is filled safely - MHRA Diane Leakey Head of Information and Communications, MHRA April 2012
2 Agenda Who is MHRA? Why we have regulation? How we regulate? Possible roles for pharmacists
3 WHO IS THE MHRA?
4 Who is MHRA? Agency of Department of Health Negotiate European and agree national legislation Advise industry, healthcare professionals, patients groups Employ over 900 staff (600 scientists & pharmacists) Created 2003 (medicines and devices) MCA and MDA
5 Why are we here aims of MHRA MHRA s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe. Protecting public health through regulation, with acceptable risk:benefit profiles for medicines and devices Promoting public health by helping people who use these products to understand their risks and benefits Improving public health by encouraging and facilitating developments in products that will benefit people
6 What does MHRA Regulate? Medicines for human use? Medical Devices? Cosmetics? Veterinary medicines? Herbal and natural medicines? Food supplements? Inspection of medicines production? Inspection of pharmacy shops? Pharmacists? Advertising?
7 Why Control Medicines and Devices?
8 1914 select committee on patent medicines Control of medicines should be a ministerial responsibility Need for Medicines Division within the Department of Health All drugs should be approved by a Medicines Commission prior to their registration Provision should be made for analysis of drugs by the Government Chemist Ingredients of preparations should be put on labels Inspectors should examine advertisements for drugs
9 Thalidomide What was it? - Harmless Sedative and for morning sickness in late 50 s and early 60 s. But what did it also do? - Teratogenicity - Phocomelia What was the outcome: - Extra safeguards with clinical trials and post marketing - Drug withdrawn And now? - Currently under research - Lenalidomide a derivative used in Myelomas
10 Clothier report What was it? - Report into deaths from Glucose injection Why did that happen? - Lack of sterility - Temperature monitoring at steam inlets of autoclave What was the outcome: - Medicines Inspectorate And now? - Medicines Inspectorates worldwide
11 How are medicines regulated? SAFETY, benefit / risk QUALITY EFFICACY Not effectiveness Not cost
12 HOW WE REGULATE MEDICINES?
13 How to control medicines? Pre-marketing Regulation of clinical trials Licensing approval before marketing Inspection of sites, GLP/GCP/GMP/GDP/GPvP Approval of all licensing activities Standard setting of pharmaceutical substances (API)
14 How to control medicines Post-marketing surveillance Literature scanning Adverse drug reaction monitoring Acting on safety issues, pseudoephedrine Better access to medicines, chloramphenical Maintaining up to date market authorisations
15 How to control medicines? Regulation Enforcement and intelligence gathering Setting of medicines policy, who can prescribe Red Tape Challenge, regulations Working with Europe, pharmacovigilance Advertising regulations, braille
16 20,000 medicines Reclassification Labels, leaflets, advertising, patient information leaflets Education internet Recall defective medicines, transplant solution Medicines testing Publish standards e.g British Pharmacopoeia Enforce the law relating to medicinal products Attempt to stop counterfeit medicines Inspections
17 Inspection Good Laboratory Practice Good Clinical Practice Good Manufacturing Practice - Orange Guide Good Distribution Practice - Turquoise Guide Good Pharmacovigilance Practice - Purple Guide (GLP) (GCP) (GMP) (GDP) (GPvP)
18 Counterfeiting Near Infra-Red Spectroscopy Non-destructive technique Minimal sample preparation Rapid measurement (< 1 minute) Chemical and physical data Differentiate between different manufacturing sites for the same product Samples analysed by nir spectroscopy Data comparison with library samples
19 Counterfeit Surveillance Project 20 mg tablets Market Samples (black) Reference samples (red) Counterfeit samples (green, blue) SIMCA-P /03/ :26:
20 Recent new stories PIP implants metal on metal hips internet drugs rat advert cough and cold treatments in children pseudoephedrine Suicide deaths from smoking cessation medicines Dangerous tanning injections Barbie drug
21 Current Issues merging with NIBSC development of CPRD, medicnal information counterfeit medicines Internet sales managing (raising) awareness of medical devices encouraging adverse drug reaction reporting Enforcement control of the supply chain Public and patient engagement
22 Types of roles at MHRA
23 Roles in Medicines Assessment clinical trial assessment marketing authorisations variations European liaison
24 Roles in post marketing surveillance adverse drug reaction reporting literature monitoring safety variations patient information
25 Roles for balancing access to medicines reclassification Co-proxamol Pseudoephedrine Chloramphenicol eye drops Azithromycin
26 Roles in maintaining and publishing the standards Inspection GMP GCP GPvP GDP GLP Defective medicine reporting centre Medicines testing scheme British Pharmacoepia
27 Roles in Device Evaluation
28 Other roles Medicines information Communications IT Development Policy development Senior management
29 Information available MHRA s WEB SITE ADDRESS: INFORMATION CENTRE: info@mhra.gsi.gov.uk MHRA 151 Buckingham Palace Road London SW1W 9SZ
MHRA Anti-counterfeiting Strategy and Supply Chain Guidance
Safeguarding public health MHRA Anti-counterfeiting Strategy and Supply Chain Guidance PQG Annual Meeting for QPs 24 Mar 2010 Nimo Ahmed Head of Intelligence Medicines and Healthcare products Regulatory
More informationquality and safety of pharmacy preparations in Europe
quality and safety of pharmacy preparations in Europe Henk Scheepers, Pharm D, Senior-Inspector Public Health Supervisory Service Health Care Inspectorate The Netherlands 1 Nothing to disclose 2 1 quality
More informationEuropean Medicines Enforcement Network
Safeguarding public health European Medicines Enforcement Network 14 th ICDRA, Singapore December 2010 Nimo Ahmed Head of Intelligence Medicines and Healthcare products Regulatory Agency Outline MHRA Enforcement
More informationREGULATORY CHALLENGES IN SOUTH AFRICA
REGULATORY CHALLENGES IN SOUTH AFRICA MEDICINES CONTROL COUNCIL SA Prof Peter Eagles Chairperson Medicines Control Council [Southern African Regional and International Symposium (SARI 2014)] 1 OUTLINE
More informationReview of Medicines Act 1968: informal consultation on issues relating to the PLR regime and homeopathy
Review of Medicines Act 1968: informal consultation on issues relating to the PLR regime and homeopathy Introduction 1. The consolidation and review of the UK medicines legislation (including the Medicines
More informationMEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH
11 MEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH Background The rules in this section are designed to ensure that advertisements that include health claims (please see Section 13 for health claims
More informationREPUBLIC OF KENYA MINISTRY OF MEDICAL SERVICES PHARMACY AND POISONS BOARD
REPUBLIC OF KENYA MINISTRY OF MEDICAL SERVICES PHARMACY AND POISONS BOARD Ensuring the provision of quality, safe and efficacious pharmaceutical products and services. FUNCTIONS OF THE BOARD BACKGROUND
More information40 Use and Supply of Drugs or Medicines in Optometric Practice
40 Use and Supply of Drugs or Medicines in Optometric Practice Guideline 40.01 The optometrist has a duty to take due care in the use of drugs in optometric practice and to only supply drugs when it is
More informationCase-by-Case Regulatory toxicology testing in Drug Development in Rare or Debilitating Disease
Case-by-Case Regulatory toxicology testing in Drug Development in Rare or Debilitating Disease David R Jones Expert Pharmaco-Toxicologist MHRA www.mhra.gov.uk David.jones@mhra.gsi.gov.uk ANY OPINIONS EXPRESSED
More informationQuality, Safety and Sourcing in Unlicensed Medicines
Quality, Safety and Sourcing in Unlicensed Medicines with Andrew Trouton Managing Director, UL Medicines Agenda Welcome What is an unlicensed medicine? When should you consider using an unlicensed medicine?
More informationIMMEDIATE DICLOFENAC NEW CONTRAINDICATIONS AND WARNINGS AFTER A EUROPE-WIDE REVIEW OF CARDIOVASCULAR SAFETY
Finance, EHealth and Pharmaceuticals Directorate Pharmacy and Medicines Division T: 0131-244 2528 E: irene.fazakerley@scotland.gsi.gov.uk 1. Medical Directors 2. Directors of Public Health 3. Directors
More informationCooperation between HALMED and GMP Inspectorate in supervision of manufacturers: Croatia s experience so far
Cooperation between HALMED and GMP Inspectorate in supervision of manufacturers: Croatia s experience so far Ana Boban, MPharm. Agency for Medicinal Product and Medical Devices of Croatia Dubrovnik, 06.05.2013.
More informationChanging practice to support service delivery
Nurse and Midwife Medicinal Product Prescribing Toolkit Authorised Medicinal Products, Off-label Prescription and Exempt Medicinal Products Toolkit Changing practice to support service delivery Introduction
More informationFrequently asked questions
13 February 2017 EMA/527628/2011 Rev. 1 Directorate This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question
More informationHealth Authority Abu Dhabi. Document Title: Policy for Recall of Drugs and Healthcare Products Document Ref. Number:
Health Authority Abu Dhabi Document Title: Policy for Recall of Drugs and Healthcare Products Document Ref. Number: PPR/DMP/DR/P0001 Version 0.9 Approval Date: August 2007 Effective Date: August 2007 Last
More informationADHD drugs, MHRA and the Concerta scandal suicides, suicide attempts and self-harm
Open Letter VII, to Dr Ian Hudson, Chief Executive of MHRA 31 March 2017 ADHD drugs, MHRA and the Concerta scandal suicides, suicide attempts and self-harm Dear Dr Hudson, I should have come back much
More informationThank you for your requests under the Freedom of Information Act Please find below responses to your questions.
Our reference: FOI/12-332 Dear Ms Mallinson Thank you for your requests under the Freedom of Information Act 2000. Please find below responses to your questions. 1. Please e-mail copies of the minutes
More information14 th International Conference of Drug Regulatory Authorities 30 th November December 2010 Singapore
14 th International Conference of Drug Regulatory Authorities 30 th November 2010 3 December 2010 Singapore CURRENT REGULATORY CHALLENGES RELATING TO HERBAL MEDICINES: ADULTERATION OF HERBAL MEDICINES
More information(Adopted by the Committee of Ministers on 19 January 2011 at the 1103rd meeting of the Ministers Deputies)
Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (Adopted by the Committee of Ministers on 19 January
More informationGPvP Symposium 2014: Welcome and Updates. 14 March 2014 Rebecca Stanbrook, Group Manager Inspections (GCP/GPvP/GLP)
GPvP Symposium 2014: Welcome and Updates 14 March 2014 Rebecca Stanbrook, Group Manager Inspections (GCP/GPvP/GLP) Agenda Housekeeping The MHRA Welcome The Day Ahead The Technology 2 Housekeeping Restrooms
More informationIssue: March 2016 PROFESSIONAL STANDARDS AND GUIDANCE FOR ADVERTISING MEDICINES AND PROFESSIONAL SERVICES
Issue: March 2016 PROFESSIONAL STANDARDS AND GUIDANCE FOR ADVERTISING MEDICINES AND PROFESSIONAL SERVICES PROFESSIONAL STANDARDS AND GUIDANCE FOR ADVERTISING MEDICINES AND PROFESSIONAL SERVICES CONTENTS
More informationLegal Framework: Counterfeit Medicines.
Legal Framework: Counterfeit Medicines. AIFA and the actions against drugs counterfeiting Marcello Chiavoni Zagreb, November 2014 Public Declaration of transparency/interests* The view and opinions expressed
More informationOverview of IMB and Integration of Cosmetics
Overview of IMB and Integration of Cosmetics Cosmetics Information Day, September 15 th 2010 Dr Lorraine Nolan Healthcare Products Distribution Irish Medicines Board 23 rd October 2008 Slide 1 Irish Medicines
More informationOverview Consumer Health Products Law and Compliance Issues
Overview Consumer Health Products Law and Compliance Issues The First Asia Pacific Pharmaceutical Compliance Congress September 2011 CHONG JIN NG Assistant General Counsel Asia Shared Legal Services Consumer
More informationGetting the best from the medicines you buy
Getting the best from the medicines you buy You can buy many medicines without needing to see your doctor. These are often called over-the-counter medicines. They are safe and effective as long as you
More informationCounterfeit Medicinal Products. FINLAND Roschier, Attorneys Ltd.
Counterfeit Medicinal Products FINLAND Roschier, Attorneys Ltd. CONTACT INFORMATION Mikael Segercrantz Robert Hagelstam Roschier, Attorneys Ltd. Keskuskatu 7 A 00100 Helsinki, Finland 358.20.506.6000 mikael.segercrantz@roschier.com
More informationThe father of Western medicine, Hippocrates (460 BC BC) is known to have used many plants and herbs for medicinal purposes. Hippocrates' use of
UNIT 11 INVESTIGATE WESTERN HERBAL PRODUCTS HISTORY OF TRADITIONAL WESTERN HERBAL MEDICINE The father of Western medicine, Hippocrates (460 BC - 377 BC) is known to have used many plants and herbs for
More informationCOPYRIGHTED MATERIAL. Introduction
1 Introduction Pharmacology is the science of drugs and their effects on biological systems. A drug can be defined as a chemical that can cause a change in a biological system; the important biological
More informationGuidelines on the Sourcing of Medicinal Products for Sale or Supply by a Retail Pharmacy Business
Guidelines on the Sourcing of Medicinal Products for Sale or Supply by a Retail Pharmacy Business to Facilitate Compliance with Regulations 5(1)(g), 6, 8 and 11 of the Regulation of Retail Pharmacy Businesses
More informationCOUNTERFEIT DRUGS IN INDIA
COUNTERFEIT DRUGS IN INDIA a part presentation from the on-going dissertation Global Threat of Counterfeit Drugs A Study Covering Extent of Problem and Anticounterfeit Measures in Europe & India By, Viraj
More informationFrom Wikipedia, the free encyclopedia
1 of 6 11/24/2010 11:43 PM From Wikipedia, the free encyclopedia The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United
More informationFOOD AND DRUGS AUTHORITY (FDA) GHANA
REGULATION OF HERBAL MEDICINE IN GHANA FOOD AND DRUGS AUTHORITY (FDA) GHANA 1 PRESENTATION OUTLINE Background Mandate Functions General overview Regulation of Herbal Medicine Cooperation in the ECOWAS
More informationNon-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients
Non-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients Pharmaceutical Society of Ireland Version 3 October 2017 Updates made following the enactment
More informationBlanka Hirschlerová. EDQM CEP conference Prague, Czech Republic
1 Experience with CEPs from a European regulatory authority perspective Blanka Hirschlerová EDQM CEP conference Prague, Czech Republic 2012 STATE INSTITUTE FOR DRUG CONTROL Agenda 2 Agenda Introduction
More informationRESOLUTION OF THE STATE GREAT KHURAL OF MONGOLIA. 11 October 2002 No: 68 Ulaanbaatar. Adoption of the Government Policy on Drugs
Translation from Mongolian RESOLUTION OF THE STATE GREAT KHURAL OF MONGOLIA 11 October 2002 No: 68 Ulaanbaatar Adoption of the Government Policy on Drugs The State Great Khural of Mongolia RESOLVES: 1.
More informationTable of ConTenTs. 1. The Agencia Española de Medicamentos y Productos Sanitarios, AEMPS: Who we are. 2. How are medicines assessed and authorised?
Table of ConTenTs 1. The Agencia Española de Medicamentos y Productos Sanitarios, AEMPS: Who we are Mission and vision Summary of activity The human team Structure 2 3 4 6 7 2. How are medicines assessed
More informationHerbal medicines and supplements for cancer patients
Herbal medicines and supplements for cancer patients Questions and answers Information for patients Pharmacy page 2 of 8 This leaflet is for all patients having treatment for cancer who are taking or thinking
More informationAGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION. (Moscow, 23 December 2014)
AGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION (Moscow, 23 December 2014) Member States of the Eurasian Economic Union, hereinafter referred
More informationThe science behind generic drugs
The science behind generic drugs Are generics manufactured to the same high quality standards? Are generics equivalent to the pioneer? Do pioneer drugs go through more testing? Should I feel confident
More informationabcdefghijklmnopqrstu
Primary and Community Care Directorate Pharmacy Division T: 0131-244 2528 F: 0131-244 2375 E: irene.foster@scotland.gsi.gov.uk 26 March 2008 abcdefghijklmnopqrstu Directors of Pharmacy Chief Executives,
More informationBILATERAL SCREENING MEETING
Negotiating Group for the Accession of the Republic of Serbia to the European Union - Chapter 28, Consumer and Health Protection BILATERAL SCREENING MEETING Chapter 28 Consumer and Health Protection Brussels,
More informationSunbeds. We believe that under-18s should not be permitted to use sunbeds and support the banning of unstaffed, coin-operated salons immediately.
October 009 Policy Statement Sunbeds The risks Cancer Research UK does not recommend the use of sunbeds for cosmetic purposes. There is growing evidence to show that the use of sunbeds increases the risk
More informationCommunity Pharmacy Practice in Norway
Community Pharmacy Practice in Norway Contributed by: Cand.pharm. Rønnaug Larsen, President, The Norwegian Association of Pharmacists Norwegian facts - Kingdom with parliamentary democracy. - Population
More informationHERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK. Presented by: Mariam Aslam
HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK Presented by: Mariam Aslam ESCOP European Scientific Cooperative On Phytotheapy (ESCOP) Founded in June 1989 as an umbrella
More informationMedical Devices. SOUTH AFRICA Bowman Gilfillan
Medical Devices SOUTH AFRICA Bowman Gilfillan CONTACT INFORMATION Llewellyn Parker Bowman Gilfillan PO Box 785812, Sandton, 2146 South Africa +27 11 669 9635 l.parker@bowman.co.za www.bowman.co.za 1. Definition
More informationPharmaceutical System in the UK
Pharmaceutical System in the UK David Kullman Medicines, i Pharmacy and Industry Group Department of Health PPRI Conference, Vienna 30 September 2011 Disclaimer Conflict of interest: Nothing to disclose
More informationCHE8000 Major Research Project A. The Complementary Medicines Reforms and Its Impact to the Complementary Medicine Industry and the Consumer
CHE8000 Major Research Project A The Complementary Medicines Reforms and Its Impact to the Complementary Medicine Industry and the Consumer Completed by: Lina Karlina (ID: 2067226) Lina Karlina (2067226)
More informationFalsified Medicines Directive (FMD) Dispensing Doctors Association Wednesday 18-Oct-17 Jerome Bertin
Falsified Medicines Directive (FMD) Dispensing Doctors Association Wednesday 18-Oct-17 Jerome Bertin Objectives What is FMD all about and when does it need to happen? Who are SecurMed and what is our role
More informationHealth Products Regulatory Authority IPAR. Public Assessment Report for a. Traditional Herbal Medicinal Product
IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Ginkgo-Biloba Pharma Nord film-coated tablets Ginkgo dry extract TR 1242/1/1 TR holder Pharma Nord ApS March 2018
More informationHeng-Jung Lien 衛生福利部食品藥物管理署. Section Chief. Food and Drug Administration, Ministry of Health and Welfare
Heng-Jung Lien Section Chief Division of Medicinal Products, Food and Drug Administration, Ministry of Health and Welfare, Taiwan, R.O.C. 衛生福利部食品藥物管理署 Food and Drug Administration, Ministry of Health and
More informationResponse to Scottish Government A Consultation on Electronic Cigarettes and Strengthening Tobacco Control in Scotland December 2014
Responseto ScottishGovernment AConsultationonElectronicCigarettesand StrengtheningTobaccoControlinScotland December2014 Contact Janice Oman Scotland Representation Manager National Pharmacy Association
More informationRecommendations 2. Council is asked to note and discuss the findings of the research and how we intend to use it.
COUNCIL Survey of contact lens wearers: research findings Meeting: 10 February 2016 Lead responsibility: Alistair Bridge (Director of Strategy) Status: for noting Project manager/paper author: Marie Bunby
More informationWorking at the MHRA A day in the life of a Pharmaceutical Assessor
Working at the MHRA A day in the life of a Pharmaceutical Assessor. Seun Sogbesan, Associate Pharmaceutical Assessor 16 th April 2015 Presentation Aims To provide an insight into the day-to-day role of
More informationSchedule 1. New marketing authorisation and renewal of marketing authorisation
and renewal of marketing Schedule 1 The Delimitation column refers to the relevant articles of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating
More informationPOISONS SCHEDULING. Monique Reyes Senior Pharmaceutical Officer Pharmaceutical Regulatory Unit NSW Ministry of Health
POISONS SCHEDULING Monique Reyes Senior Pharmaceutical Officer Pharmaceutical Regulatory Unit NSW Ministry of Health Topics Schedules of the Poisons Standard (Cth) Poisons and Therapeutic Goods Act 1966
More informationFDLI s Enforcement, Litigation, and Compliance Conference. Center for Tobacco Products Office of Compliance and Enforcement 2017 Update
FDLI s Enforcement, Litigation, and Compliance Conference Center for Tobacco Products Office of Compliance and Enforcement 2017 Update Ann Simoneau, Director Office of Compliance and Enforcement Center
More informationMHRA Pharmacovigilance System Master File (PSMF) Inspection Findings
MHRA Pharmacovigilance System Master File (PSMF) Inspection Findings Gretel Sakyi Medical Information and Patient Safety Manager AstraZeneca UK 07 June 2018 Agenda MHRA inspections How inspectors use the
More informationWhich was the greatest problem with patent medicines in early America that lead to drug legislation?
Pharmacology Connections to Nursing Practice 3rd Edition Adams Test Bank Full Download: http://testbanklive.com/download/pharmacology-connections-to-nursing-practice-3rd-edition-adams-test-bank/ Adams
More informationOverview of the PAHO strategy and activities to strengthen National Regulatory Authorities in the Americas
Overview of the PAHO strategy and activities to strengthen National Regulatory Authorities in the Americas Ma. de los Angeles Cortes Regional Advisor on Vaccines and Biologicals HSS/MT Annecy, France March
More informationReport. Uganda Pharmaceutical Sector Scan JUNE 2010
Report On the Uganda Pharmaceutical Sector Scan Part of Component 1 of MeTA Baseline Assessments JUNE 2010 Drafted by consultants: 1. Samuel Balyejjusa, B.Pharm., MPH 2. Paschal Mujasi, B.Pharm., MBA 3.
More informationFundamentals of Pharmacology for Veterinary Technicians Chapter 1
1906 1914 1933 1937 1938 1941 1951 1965 1968 1970 1970 1972 1972 1983 1984 1988 1994 1994 1996 1997 2001 2003 2008 The original Pure Food and Drug Act is passed by Congress on June 30 and signed by President
More informationChief Dental Officer England: Advice on commercial practice of online registered dental practitioners selling patient group directions for NHS
Chief Dental Officer England: Advice on commercial practice of online registered dental practitioners selling patient group directions for NHS England commissioned services. Chief Dental Officer England:
More informationUSE OF UNLICENSED MEDICINES AND OFF-LABEL MEDICINES WHERE A LICENSED MEDICINE IS AVAILABLE
NHS Scotland Directors of Pharmacy and Scottish Association of Medical Directors USE OF UNLICENSED MEDICINES AND OFF-LABEL MEDICINES WHERE A LICENSED MEDICINE IS AVAILABLE CONSENSUS STATEMENT This consensus
More informationLOGO. Falsification of Medicines. Drug Chemistry and Technology Basics, Cleaner Production and Mega-Trends in Pharmaceutical Industry
LOGO Drug Chemistry and Technology Basics, Cleaner Production and Mega-Trends in Pharmaceutical Industry Falsification of Medicines Dr. As. Prof. Anastasiya Sladkova Dr. Sci. Prof. Natalya Loginova 1 Questions
More information1. Introduction. 2. Role of PSI as Pharmacy Regulator
1. Introduction 1.1. I would like to begin by thanking the Committee for inviting the Pharmaceutical Society of Ireland here today to assist in the Committee s on-going scrutiny of the Cannabis for Medicinal
More informationRegulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017
Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017 Prof. Dr. Werner Knöss, Dr. Jacqueline Wiesner TradReg2017 Germany September 2017 Page 1 Federal Institute for
More informationPIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 040-1 3 Appendices 1 January 2019 PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES PIC/S January 2019 Reproduction
More informationRegulatory Framework for Medical Devices in South Africa. 23 November 2018 Andrea Keyter Deputy Director: Medical Devices
Regulatory Framework for Medical Devices in South Africa 23 November 2018 Andrea Keyter Deputy Director: Medical Devices Medicines and Related Substances Act, 1965 (Act 101 of 1965) Act 72 of 2008 and
More informationThe Danish Medicines Agency s availability strategy
låst DECEMBER 2016 The Danish Medicines Agency s availability strategy 2017 2021 Danish Medicines Agency, 2016 This publication may be freely quoted with appropriate acknowledgement of the source. Images
More informationHarmonization effort for OTC monograph in Taiwan. Ms. Hsueh-Yung (Mary) Tai Deputy Director, Division of Medical Product, Taiwan FDA
Harmonization effort for OTC monograph in Taiwan Ms. Hsueh-Yung (Mary) Tai Deputy Director, Division of Medical Product, Taiwan FDA Outline Background OTC drug registration OTC monographs Future directions
More informationMarket surveillance of medical devices
Market surveillance of medical devices A joint action on market surveillance of medical devices to reinforce public health protection Information for healthcare professionals Introduction The European
More informationInformationsbeauftragter und Arzneimittelwerbung / Person designated responsible for information and advertising of medicinal products
Informationsbeauftragter und Arzneimittelwerbung / Person designated responsible for information and advertising of medicinal products Sofie Regner BBSG Wien, 8.11.2016 www.ages.at Austrian Agency for
More informationThe European Medicines Agency (EMA)
The European Medicines Agency (EMA) Nathalie Bere and Maria Mavris Public Engagement Department EMA Training Day 21 November, 2017 An agency of the European Union What is the European Medicines Agency
More informationGuidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry DRAFT GUIDANCE This guidance
More informationParallel trade: are industry concerns real or imagined?
Parallel trade: are industry concerns real or imagined? Steve Chaplin MSc, MRPharmS The parallel trade in medicines is claimed to save money for the NHS, but results in lost profits for the pharmaceutical
More informationTHE MEDICRIME CONVENTION
Council of Europe THE MEDICRIME CONVENTION Fighting the falsification of medical products and similar crimes The Medicrime Convention in a few words Crime linked to the manufacture, distribution and sale
More informationUpdate from FDA Office of Regulatory Affairs
Update from FDA Office of Regulatory Affairs Ellen F. Morrison Assistant Commissioner for Medical Products and Tobacco Operations Office of Regulatory Affairs U.S. Food and Drug Administration 1 The Impact
More informationTHE MEDICRIME CONVENTION
Council of Europe THE MEDICRIME CONVENTION Fighting the falsification of medical products and similar crimes The MEDICRIME Convention in a few words Crime linked to the manufacture, distribution and sale
More informationCouncil of Europe The Medicrime Convention. Combating counterfeiting of medical products and similar crimes
Council of Europe The Medicrime Convention Combating counterfeiting of medical products and similar crimes Counterfeiting of medical products and similar crimes involving threats to public health are a
More informationSubmission to the Misuse of Drugs Amendment Bill September Society and its Role and Functions. 29 September 2010
PHARMACY HOUSE 124 DIXON STREET PO BOX 11 640 WELLINGTON NEW ZEALAND TELEPHONE 04 802 0030 FAX 04 382 9297 EMAIL p.society@psnz.org.nz WEBSITE www.psnz.org.nz 29 September 2010 Clerk of the Health Committee
More informationThe Society has considered the proposals contained in the consultation document and makes the following principal comments:
Tobacco Consultation Department of Health Room 712 Wellington House 133-135 Waterloo Road London SE1 8UG Mark Nelson Chair of the Practice Committee Pharmaceutical Society of Northern Ireland 73 University
More informationMedicines and Cosmetics Regulation Unvalidated References:
Medicines and Cosmetics Regulation 2002 Unvalidated References: This reprint of this Statutory Instrument incorporates all amendments, if any, made before 25 November 2006 and in force at 16 May 2002....
More informationCouncil of Europe The Medicrime Convention
Council of Europe The Medicrime Convention Combating counterfeiting of medical products and similar crimes What is a counterfeit medical product? It is a product with a deliberately false representation
More informationBill C-51 and Natural Health Products - The Facts
Bill C-51 and Natural Health Products - The Facts 1. How will Bill C-51 change the way natural health products are regulated? Bill C-51 will not affect the way that natural health products are regulated
More informationEnsuring protection of public health and patients in member states: priorities, constraints, opportunities
Ensuring protection of public health and patients in member states: priorities, constraints, opportunities Dr. Christa Wirthumer-Hoche AGES Austrian Medicines and Medical Devices Agency Vienna, Austria
More informationWHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS
WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS SEPTEMBER 23, 2009 COUNCIL OF THE CONVENTION SECTION ON THE QUALITY OF FOOD INGREDIENTS AND DIETARY SUPPLEMENTS INTRODUCTION The 1994 Dietary Supplement
More informationPublic Assessment Report for a Traditional Herbal Medicinal Product for Human Use
IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Agnus castus oral drops Tincture of Agnus castus fruit TR2309/017/001 A. Vogel Ireland Limited 28 November 2018 CRN008R68
More informationAdditional monitoring of medicines and direct patient reporting impact on the package leaflet
Additional monitoring of medicines and direct patient reporting impact on the package leaflet EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) - 30 th November
More informationSeven years of EU pharmaceutical regulation in Malta*
Seven years of EU pharmaceutical regulation in Malta* In an era of globalization, governments are expected to provide safety and welfare for citizens while ensuring a level playing field and boosting competitiveness
More informationTOWARDS SAFE MEDICINES. A guide to the control of safety, quality and efficacy of human medicines in the United Kingdom.
TOWARDS SAFE MEDICINES A guide to the control of safety, quality and efficacy of human medicines in the United Kingdom. C Copyright. This document is MCA copyright and must not be duplicated without permission.
More informationREPUBLIC OF LITHUANIA LAW ON PHARMACY 22 June 2006 No X-709 Vilnius CHAPTER I GENERAL PROVISIONS
REPUBLIC OF LITHUANIA LAW ON PHARMACY 22 June 2006 No X-709 Vilnius CHAPTER I GENERAL PROVISIONS Article 1. Purpose of the Law 1. This Law shall regulate pharmaceutical and other activity related to medicinal
More informationMOTION FOR A RESOLUTION
EUROPEAN PARLIAMT 2009-2014 Plenary sitting 07.3.2012 B7-0000/2012 MOTION FOR A RESOLUTION further to Question for Oral Answer B7-0000/2012 pursuant to Rule 115(5) of the Rules of Procedure on Defective
More informationHow is the introduction of a new medicine regulated in the UK?
Information provided to Duchenne muscular dystrophy patient organisations regarding Raxone (idebenone) and the Early Access to Medicines Scheme in the UK (EAMS 46555/0001) A medicine called Raxone, which
More informationBRITISH PHARMACOPOEIA COMMISSION EXPERT ADVISORY GROUP (EAG): MEDICINAL CHEMICALS 1 (MC1) SUMMARY MINUTES
BRITISH PHARMACOPOEIA COMMISSION EXPERT ADVISORY GROUP (EAG): MEDICINAL CHEMICALS 1 (MC1) SUMMARY MINUTES A meeting of Expert Advisory Group (EAG): Medicinal Chemicals (MC1) was held at 151 Buckingham
More informationMedidée Services SA. Nano-Tera.ch. 05 February 2015 part 4. Intro ISO GMP - GLP Pierre-Alain Sommer
Nano-Tera.ch 05 February 2015 part 4 Intro ISO GMP - GLP Pierre-Alain Sommer Pierre-alain.sommer@medidee.com www.medidee.com Nano-Tera 2015 05.02.2015 Introduction to ISO 13485, cgmp s and GLP s Context
More informationCurriculum Vitae. Lone Cleveland Andersen. Courses
Courses and continuing education, listed by subjects. GMP courses API Curriculum Vitae Lone Cleveland Andersen Courses ICH Q7; Compliance for API s manufactured by cell culturing and fermentation, European
More informationPROVISIONAL TRANSLATION
- 3 - CROATIAN PARLIAMENT 1035 Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby issue the DECISION PROMULGATING THE ACT ON AMENDMENTS TO THE MEDICINAL PRODUCTS ACT I hereby
More informationHow Might Medicinal Regulators Evolve in their Expectations for ENDS? David M Graham Chief Impact Officer - NJOY
How Might Medicinal Regulators Evolve in their Expectations for ENDS? David M Graham Chief Impact Officer - NJOY 4 Years Ago The Regulation of Nicotine-Containing Products Jeremy Mean 2015 The fact that
More informationFoodDrinkEurope Position on GLP studies
FoodDrinkEurope Position on GLP studies Content of the presentation Introduction to GLP Importance of GLP for the food industry Use of GLP based on the example of novel foods Conclusions GLP what is it?
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL GUIDELINES and FORMS TABLE OF CONTENTS 1 Guidelines and Forms 1.01 Index to Guidelines and Forms 2 Human Medicines 2.01 General information 2.02 Pharmaceutical and Analytical
More information