Editorial Calendar 2014
|
|
|
- Christopher Taylor
- 8 years ago
- Views:
Transcription
1 Editorial Calendar 2014 IPI is Peer Reviewed. Please refer to the Editorial Guidelines section on the website for Peer Review Protocol and Authors Guidelines. The topics and subjects listed in the Editorial Calendar are special features and focuses. Please refer to the media information for a list of general topics that will be featured in IPI throughout Editorial topics listed are subject to changes, according to the movement of the industry. We will be pleased to hear from you if you have relevant topics you would like to contribute within the journal. Please all your suggestions to info@pharmapubs.com Current News and Press Releases can also be ed to the above address and will be hosted at or featured in the IPI Weekly Newsletter at our discretion.
2 Volume 6 Issue 1 February 2014 Submission Deadline 15 th January > Intellectual Property & Patent Law > Pharmacovigilance / Legislation > Clinic to Commercialization > Quality Assurance / Quality Control > Child resistant packaging policies > Audience Segmentation: Personalized Marketing > ectd Regulations > Market Access Strategies > Improving Antibody Efficacy > Oral Drug Delivery > Stem Cells in Therapeutics > Formulation & Excipients > Fragment Based Drug Design > Pulmonary Drug Delivery > Injectable Pens & Self Injection > Biologics & Therapeutics > Smart Pill technology > Ethics Committee & Review Boards > Adaptive Personalised Medicine > Biomarkers > Clinical Patient Recruitment > Data Management > Late Stage Research (Phase II IV) > Patient Recruitment & Retention > Adaptive > CTS / CTMS > Pharmacokinetics (PK Studies) > Biodynamic > Named Patient Programme > Therapeutic Vaccine > Imaging, ECG & Core Labs > CAP Accreditation > Temperature Controlled Logistics > Analytical Labs & Testing > LIMS > Cool / Cold Chain > Margins & Operating Efficiencies > Pre Filled Syringes / Self Injections > Active Ingredients & Fine Chemicals > Ingredients & Intermediates > Sterile Fill Finish > Blow Fill Seal Technology > Lyophilisation & Freeze Drying > Containment Technology > TOC / HPLC > Softgel Technology > The Suitability of Formulations for Specific Pharmaceutical Applications > Analytical Testing > Patient Adherence > Braille > Child resistant & Senior Friendly > Sterile / Sterile Closures > IV Bags & Delivery Systems > Moisture Barrier > DIA Euro Meeting > Interphex (New York) > BIO Trinity 2014 > Anglo Nordic > 23 rd Partnership in > Pharmapack (Paris) (USA) > BIO Europe Spring (Torino) > Interpack (Dusseldorf) > SMi Control Release 2014 > SMi Logistics Special Biopharmaceutical Outsourcing Supplement
3 Volume 6 Issue 2 May 2014 Submission Deadline 15 th April 2014 > FDA Inspection & Validation > Period on New Drugs > Health Economics > ICH GCP Guidelines > Patent Law > Insurance > Epidemiology > Antibody Drugs for Oncology > Molecular Technology > Parenteral > Nano Technology > Custom Antibodies > Drug Implants > In vivo / In vitro > Women s Health > Prefilled Injection Systems > Tableting (New Tablet Press generation) > Preclinical > PK / PD Studies > Imaging Technology > EDC / epro > IVRS / IWRS / IXRS > Physician Liability & Ethics Review > Phase 1 / Early Stage > Cancer / Immunotherapy (Development of Monoclonal Antibodies) > Managing Adverse Reactions > eclinical Solutions > Patient Safety & Clinical Monitoring > CDISC > Comparator Drug Supply > Phase 1 > Imaging & Data Collection > Cool Chain & Cold Chain > IVRS / IWRS / IXRS > E Procurement > Hazardous Cargo > Temperature Controlled Supply Chain > Leak Detection & Vision System > Quality Control & Quality Assurance > FDA & EMEA Facility Compliance > Environmental Protection & Facility Management > Solid Dosage Form production > Raman Spectroscopy > Filtration & Milling > Blending & Mixing Technologies > Stability Testing & Shelf Life Management > Moisture Absorption & Moisture Barrier > Anti-Counterfeiting & Brand Protection > RFID Coding & Marking > > Patient Information > 50 th DIA Annual Meeting > SMi - Pharma Outsourcing & Procurement Summit > BIO USA (San Diego)
4 Volume 6 Issue 3 September 2014 Submission Deadline 15 th August 2014 > Quality Assurance / Quality Control > Market Entry & Authorisation > FDA Bio Research Monitoring > Programme Protecting Human Subjects > FDA/EMA / WHO Validation & Accreditation > Intellectual Property > Insurance & Liabilities > Toxicity Assays > Inhalation & Nasal Drug Delivery MDI s & DPI s > Diabetes > Advances in Stem Cell Technology > Imaging Technologies (Safety & Testing) > Cardiovascular / Metabolic > Biopharmaceutical Lab Services > Supporting Drug Safety > Analytical Testing > Medical Imaging > ectd > Bio Equivalence Studies > Medical Devices > SMO/ Site Management > Pharmacovigilance & Drug Safety > Human Embryonic Stem Cells (hesco) > Cardiovascular Safety / QTC Prolongation > CTS/CTMS > Rescue Studies > CDISC/CDASH > Hepatic & Renal Impairment > Targeted Populations > Global Central Laboratories > Cardiology > Safety Testing > Time Sensitive Shipment > RFID Tracking Systems > Optical Sensing > Emerging Markets Customs > Parenteral > Semi Solids / Creams & Ointments > Neutraceuticals > Topical > IV Drug Delivery > Robotics & CAM > Filtration & Separation > Prefilled Injectable > Inhalation > PAT & Quality by Design > Labelling & Bar-coding > Patient Information Leafleting > Translation & License Regulation > Electronic Notification & Intelligent to enhance patient compliance > Booklet Labelling > Authentication & Brand Protection Special > CPHI / ICSE / PMEC / BIOPH 2014 (Paris) > BIO EUROPE Autumn > > ScanBalt 2013 > PPMA (Process Machinery Association) Outsourcing Supplement (Contract Services)
5 Volume 6 Issue 4 November 2014 Submission Deadline 15 th October 2014 > FDA / EMEA / WHO > Helsinki Declaration > Validation & Accreditation what it means in the current climate. > Vaccines & Adjuvant Prevention & Cure > Cardiovascular Safety > FDA/EMA Inspections > Antibody Drugs for Oncology > Parenterals > Cell Processing Tools > Fragment Based Drug Design > Custom Antibodies > Transdermal > Prefilled Injection Systems > CNS Alzheimer s > Cognitive Research > Managing Adverse Reactions > Phase I IV > Preclinical > PharmacoEconomics > IMP & Supply > Medical Imaging > Imaging in Oncology > Lab Validation > Temperature Controlled / Data logging > LIMS in Shipment > Central, Global, Analytical Labs > Lab Validation > Imaging in Oncology > Temperature Controlled/Data Logging > LIMS in Shipment > Dosage Form Production > Lean / Six Sigma Solids > PAT Capsules > Tooling > Aseptic Processing > Pure Water / WFI > Clean Room & Contamination Control > Peptide Synthesis > Pre-formulation > PAT & Quality by Design > Liquids & Sachets > Blistering & De-Blistering Machines > Brand Protection > Sterile Fill Finish > Prefilled Injection Systems > RFID Coding & Marking > > ICSE / CPHI / BIOPH / PMEC India > Genesis
6
An integrated global healthcare company
An integrated global healthcare company 1 A Mission to create healthier communities globally Zydus Cadila is dedicated to life In all its dimensions. Our world is shaped by a passion for innovation, commitment
Life Science Sector Opportunities Northern Ireland. Clinical Trials. investni.com
Life Science Sector Opportunities Northern Ireland investni.com Introduction Clinical trials commonly refer to testing the effectiveness of experimental drugs and are typically categorised into four phases;
Overview of Phase 1 Oncology Trials of Biologic Therapeutics
Overview of Phase 1 Oncology Trials of Biologic Therapeutics Susan Jerian, MD ONCORD, Inc. February 28, 2008 February 28, 2008 Phase 1 1 Assumptions and Ground Rules The goal is regulatory approval of
Introduction to pharmaceutical technology
Introduction to pharmaceutical technology Marie Wahlgren Chapter 1 What is the topics of today Introduction to the course Introduction to the project assignment How to choose a new drug formulation 1 Contacts
A clinical research organization
A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced
RADIOPHARMACEUTICALS BASED ON MONOCLONAL ANTIBODIES
RADIOPHARMACEUTICALS BASED ON MONOCLONAL ANTIBODIES Guideline Title Radiopharmaceuticals based on Monoclonal Antibodies Legislative basis Directives 65/65/EEC, 75/318/EEC as amended, Directive 89/343/EEC
Importing pharmaceutical products to China
Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval
GMP Pharma BV. Netherlands
GMP Pharma BV Netherlands Connecting the European & Indian Pharmaceutical, Biotechnology and Biopharmaceutical Industry for parallel growth and solicitation. About Us: GMP Pharma BV is a multisource organization
Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials
Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials Ron Hinkel, Director Quality Systems BioReliance Inc. Patti Rossman, President Globiox Purpose Keep pace
Microbiology and Auditing. Don Singer
Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011 Through the eyes of a Microbiologist Microbiology Audit = Inspection / Investigation Systematic Auditing Planning
Clinical Data Management Overview
The 2 nd Clinical Data Management Training Clinical Data Management Overview Andrew Taylor ( 安 泰 乐 ), M.S. Head of Clinical Data Management August 30, 2010 Learning Objectives Overview of Process Related
Overcoming Challenges in the Manufacturing of Pre-Filled Syringes. Farvea, a new comer in the PFS world PFS Tech 2016. June 2016 pharma@fareva.
Overcoming Challenges in the Manufacturing of Pre-Filled Syringes Farvea, a new comer in the PFS world PFS Tech 2016 June 2016 pharma@fareva.com Our presence around the world 11 countries 35 sites 12
ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING
ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING For More Information on Submission of an ANDA in Electronic Common Technical Document (ectd) Format
Annex 9 Guide to good storage practices for pharmaceuticals 1
World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 9 Guide to good storage practices for pharmaceuticals 1 1. Introduction 125 2. Glossary 126 3. Personnel 128 4. Premises and facilities
Programme Guide PGDCDM
Post Graduate Diploma in Clinical Data Management and Biostatistics with SAS Programme Guide PGDCDM School of Health Sciences Indira Gandhi National Open University WHY THIS PROGRAMME? The Post Graduate
Valentina Gualato, Ph.D. Process Development Scientist
COMPANY PRESENTATION Quality and Innovation Valentina Gualato, Ph.D. Process Development Scientist MISSION areta international is a biotech company dedicated to the contract development and manufacturing
General Principles for the Safety Assessment of Excipients
General Principles for the Safety Assessment of Excipients General Characteristics of the Pharmaceutical Excipients Classification of excipients The Safety Assessment of Pharmaceutical Excipients : how
e-clinical Trial Solutions Market to 2018
e-clinical Trial Solutions Market to 2018 Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies GBI Research Report Guidance
Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management
Brochure More information from http://www.researchandmarkets.com/reports/2226324/ Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management Description:
Overview of Drug Development: the Regulatory Process
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger
School of Pharmacy TEMPLE UNIVERSITY
School of Pharmacy TEMPLE UNIVERSITY Regulatory Affairs and Quality Assurance Graduate Program Te mple Unive rsity School of Pharmacy Re gulatory Affairs and Quality Assurance Graduate Program 4 25 Comme
NEW BRUNSWICK GRADUATION REQUIREMENTS PROGRAM OBJECTIVES PROGRAM OVERVIEW CAREER OPPORTUNITIES PREREQUISITES
NEW BRUNSWICK *Please scroll to see other provinces. PHARMACY TECHNICIAN PROGRAM OBJECTIVES The Pharmacy Technician diploma program will provide the student with the required knowledge base and practical
C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to
C 5 chemical development contract research custom synthesis cgmp API manufacturing commercial production Welcome to ChemCon Company profile Company profile ChemCon offers outstanding chemical services
ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit CPMP/ICH/380/95 ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products
Pharmaceuticals Production Services Boehringer Ingelheim. Our expertise in world-class contract manufacturing for your success
Pharmaceuticals Production Services Boehringer Ingelheim Our expertise in world-class contract manufacturing for your success Successful partnership Dr Wolfram Carius Head of Corporate Division Pharmaceuticals
Understanding Our Curriculum
Understanding Our Curriculum One question that comes up quiet frequently when talking with preceptors is what are we teaching our students and when are they exposed to certain classes. Below you will find
Annual Report on Form 20-F
Annual Report on Form 20-F 2 Teva at a Glance Founded in 1901 by three young pharmacists, today Teva Pharmaceutical Industries Ltd. is a leader in the global pharmaceutical industry, providing medicines
BioBusiness Biopharmaceutical Ingredients Recombinant albumins & albumin fusion Dermot Pearson, Strategic Product Director, NZ Biopharma
BioBusiness Biopharmaceutical Ingredients Recombinant albumins & albumin fusion Dermot Pearson, Strategic Product Director, NZ Biopharma 2 Novozymes solutions dedicated to the biopharmaceutical industry
CATEGORY Advertising. CATEGORY Biopharmaceutics. CATEGORY Biosimilarity
CATEGORY Advertising Guidance Agenda: New & Guidances CDER is Planning to Publish During Calendar Year 2016 (See the Good Guidance Practices (GGPs) regulation on this Web page or 21 CFR 10.115 for details
ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals. Step 5
European Medicines Agency July 1996 CPMP/ICH/140/95 ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals Step 5 NOTE FOR GUIDANCE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS
Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management
Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Reference Code: GBIHC088MR Publication Date: June 2011 Biopharmaceutical companies
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal
GUIDELINES FOR NUCLEAR PHARMACY TECHNICIAN TRAINING PROGRAMS
GUIDELINES FOR NUCLEAR PHARMACY TECHNICIAN TRAINING PROGRAMS Prepared by Ad Hoc Committee on Nuclear Pharmacy Technicians Nuclear Pharmacy Section Academy of Pharmacy Practice and Management American Pharmaceutical
Clinical Supply Chain Management. Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management
Clinical Supply Chain Management Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management GBI Research Report Guidance GBI Research Report Guidance The report focuses on the current
ENDORSED BY THE GOVERNANCE COMMITTEE
Guideline for the Preparation or Manipulation of Monoclonal Antibodies (MABs) and related compounds such as Fusion Proteins, used in the Treatment of Cancer Date Approved by Network Governance July 2012
Glossary of Clinical Trial Terms
Glossary of Clinical Trial Terms ADVERSE REACTION: (Adverse Event): Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental
Course Curriculum for Master Degree in Clinical Pharmacy
Course Curriculum for Master Degree in Clinical Pharmacy The Master Degree in Clinical Pharmacy is awarded by the Faculty of Graduate studies at Jordan University of Science and Technology (JUST) upon
Annex 7 Guidelines on pre-approval inspections
World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the
Catalent Biologics & Clinical Supplies The SMART Solution
Catalent Biologics & Clinical Supplies The SMART Solution Advanced Technology and Integrated Solutions From DNA to Clinical Supply & Cold Chain Distribution Dr. Florian Schwaak Account Manager Germany
11 MEDICATION MANAGEMENT
1 11 MEDICATION MANAGEMENT OVERVIEW OF MEDICATION MANAGEMENT Depending on the size, structure and functions of the health facility, there may be a pharmacy with qualified pharmacists to dispense medication,
Guidance for Industry
Guidance for Industry Changes to an Approved NDA or ANDA U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2004 CMC Revision
How To Understand The Pharmacology Of The Pharmaceutical Industry
It; MM MODERN Ul NDUSTRY 77 /
Post-Approval Change Management: Challenges and Opportunities An FDA Perspective
CMC Workshop From Drug Development to Global Supply to Patients April 15-17, 2013, Washington, DC Post-Approval Change Management: Challenges and Opportunities An FDA Perspective Christine M. V. Moore,
Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products
Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
EDUCATOR S LESSON PLAN
EDUCATOR S LESSON PLAN Pharmacy Technician Training Program Student Version Orientation Orientation introduces the student to basic terms and definitions. An introduction to the Pharmacy Technician Certification
Manufacturing Services. Operational solutions for chemical, pharmaceutical, nutraceutical and cosmetic companies
Manufacturing Services Operational solutions for chemical, pharmaceutical, nutraceutical and cosmetic companies Bringing ideas to life We built our Swiss pharmaceutical company on one idea born over 70
BIOTECHNOLOGY OPERATIONS
BIOTECHNOLOGY OPERATIONS Principles and Practices Michael J. Roy TECHNISCHE INFORMATION SBIBLIOTHEK UNIVERSITATSBIBLIOTHEK HANNOVER CRC Press TaylorStFrancis Croup Boca Raton London New York CRC Press
Media Planner 2016. Sales Manager - Helen Conyngham E: helen.conyngham@texerepublishing.com T: +44 (0) 774 705 7369
$ Media Planner 2016 Publisher - Richard Hodson E: richard.hodson@texerepublishing.com T: +44 (0) 770 913 7760 Editorial - Stephanie Sutton stephanie.sutton@texerepublishing.com Sales Manager - Helen Conyngham
Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA
PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical
Catalog. Global Education. and Training. Global Expertise Trusted Standards Improved Health
Global Education Catalog 2013 2014 and Training Global Expertise Trusted Standards Improved Health USP s mission is to improve global health through public standards and related programs that help ensure
Presented at: Jefferies 2015 Global Healthcare Conference
Presented at: Jefferies 2015 Global Healthcare Conference Agenda 1 Overview & Service Platforms 2 Adaptability, Scalability & Expansion Plans 3 Best Practices 4 Blue Chip Customer Base 5 Roadmap of Evolution
Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015
Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient
EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE
EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE S1A. Current Step 4 version
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES
Session 6 Clinical Trial Assessment Phase I Clinical Trial
L1 Session 6 Clinical Trial Assessment Phase I Clinical Trial Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;
DIRECTIVE 65/65/EEC Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of
Regulation and Risk Management of Combination Products
Regulation and Risk Management of Combination Products Katherine Ulman Associate Scientist Global Regulatory Compliance Manager Dow Corning Healthcare Jim Curtis Senior Specialist, Healthcare Applications
GDUFA Regulatory Science Update
GDUFA Regulatory Science Update Robert Lionberger, Ph.D. Director Office of Research and Standards Office of Generic Drugs Center for Drug Evaluation and Research, FDA GPhA Annual Meeting Feb 9, 2015 Goals
Marken For more information visit: www.marken.com
ceocfointerviews.com All rights reserved! Issue: January 18, 2016 The Most Powerful Name in Corporate News Global Supply Chain Service Provider to the Pharmaceutical and Healthcare Industry We are tracking
Guidance for Industry
Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products Center for
Pharmacy Technician Training Program. Minimum Competencies
1. Pharmacy Practice Pharmacy Technician Training Program Minimum Competencies 1.1 The candidate shall be familiar with the mission of pharmacy and the various permitted pharmacy practice sites. The candidate
NEW CHEMICAL ENTITIES
NEW CHEMICAL ENTITIES PIONEERING PARTNER FOR PEPTIDES With more than 40 years of expertise in peptide synthesis, a track record in process development, large-scale manufacturing and outstanding product
GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors
GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors This course is a distance-learning program that will culminate in a Graduate
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Food, Medicine and Health Care Administration and Control Authority
Food, Medicine and Health Care Administration and Control Authority Bio equivalence Study Registration Requirements in Ethiopia (Four Countries Experience) Mengistab W.Aregay (Bpharm, MSc. in Health Monitoring
Guide to The Notification System for Exempt Medicinal Products
Guide to The Notification System for Exempt Medicinal Products AUT-G0090-1 10 JULY 2014 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.
Guideline on dossier requirements for Type IA and IB notifications
Guideline on dossier requirements for Type IA and IB notifications In accordance with Regulation (EC) No 726/2004 and Directives 2001/83/EC and 2001/82/EC, a common approach to the procedures for variations
Working with ICH Quality Guidelines - the Canadian Perspective
Working with ICH Quality Guidelines the Canadian Perspective Krishnan Tirunellai, Ph. D. Bureau of Pharmaceutical Sciences Therapeutic Products Directorate Health Canada December 3, 2008 Outline Introduction
Guidance for Industry
Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products For questions on the content of the guidance,
ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products. Step 5
European Medicines Agency August 2003 CPMP/ICH/2736/99 ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products Step 5 NOTE FOR GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW
PHARMACEUTICAL DEVELOPMENT
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL DEVELOPMENT Q8(R2) Current Step
Library Guide: Pharmaceutical GMPs
Library Guide: Pharmaceutical GMPs Table of Contents Overview...3 Courses Listed by Functional Area... 4 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)... 7 A Tour of the FDA
EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES
EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES Introduction The WHO Prequalification of Medicines Programme (PQP) was established to provide UN
Pharmacy Investigational Drug Services for Clinical Research
Pharmacy Investigational Drug Services for Clinical Research Jennifer Colon, PharmD, MS, MBA Pharmacy Clinical Specialist-Investigational Drug Services Temple University Hospital Adjunct Clinical Professor-Temple
Non-clinical development of biologics
Aurigon Life Science GmbH Non-clinical development of biologics Requirements, challenges and case studies Committed to Life. Sigrid Messemer vet. med. M4 Seminar March 10 th 2014 Aurigon - your full service
Taking a Leap Toward Global Supply Chain Efficiency
Taking a Leap Toward Global Supply Chain Efficiency 2 Taking a Leap Toward Global Supply Chain Efficiency INTRODUCTION PROBLEM STATEMENT Pharmaceutical manufacturers face a number of challenges to produce
Recent Updates on European Requirements and what QPs are expected to do
Recent Updates on European Requirements and what QPs are expected to do QP Forum 28/29 November 2013, Lisbon Dr. Bernd Renger Modified: Georg Goestl 1 Written Conformation for API-Import Actual Status
Volume 2B Notice to Applicants. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD)
Volume 2B Notice to Applicants Medicinal products for human use Presentation and format of the dossier Common Technical Document (CTD) Introduction Edition June 26 Module 1 Edition May 28 Module 2 Edition
Guideline on stability testing for applications for variations to a marketing authorisation
21 March 2014 EMA/CHMP/CVMP/QWP/441071/2011- Rev.2 Committee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on stability testing for applications
MINISTRY OF HIGHER EDUCATION UNIVERSITY OF HAIL COLLEGE OF PHARMACY
MINISTRY OF HIGHER EDUCATION UNIVERSITY OF HAIL COLLEGE OF PHARMACY Academic Reference Standards of Pharm.-D Program College of Pharmacy-University of Hail May The Major shift in the health-care system
FILTRATION SOLUTIONS PhARmAceUTIcAL manufacturing FILTRATION SPecIALISTS
FILTRATION SOLUTIONS Pharmaceutical Manufacturing filtration specialists Delivering quality filtration products As one of Europe s leading manufacturers of process filters, Amazon Filters is able to offer
Scientifically Minded. Medically Driven.
Scientifically Minded. Medically Driven. MEDICALLY DRIVEN. 01 SCIENTIFICALLY MINDED. At Worldwide Clinical Trials we strategically balance science, medicine, operations and commercial intelligence to achieve
Is a Career in the. Pharmaceutical. Check out our online Student Center to find out more: www.aaps.org/forstudents
Is a Career in the Pharmaceutical Sciences Right for Me? Check out our online Student Center to find out more: www.aaps.org/forstudents How Do I Know If a Career in the Pharmaceutical Sciences is Right
Investor Presentation NASDAQ:BLFS
Investor Presentation NASDAQ:BLFS Safe Harbor Statement This presentation contains forward-looking statements, including, but not limited to, statements concerning the company s anticipated business and
Public Assessment Report. Scientific discussion. Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules
Public Assessment Report Scientific discussion Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules (calcium carbonate and cholecalciferol) NL License RVG: 111783 Date: 12 March 2015 This
Changes to an Approved Product
Changes to an Approved Product Chemistry, Manufacturing and Controls By Khandan Baradaran, PhD and Peggy Berry, MBA, RAC It is a huge achievement for any company to obtain licensing rights to an approved
Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH
Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH VWR enables the advancement of science by providing high-quality chemicals and services, customized to your
Technology and Expertise Add Operational Value to Medical Device Trials
Technology and Expertise Add Operational Value to Medical Device Trials Copyright 2015 Medidata Solutions. Medidata Solutions and other trademarks reserved in the US and globally. Medidata and other marks
Accreditation of Master of Pharmacy Degrees
Accreditation of Master of Pharmacy Degrees Interim standards, Sept 2010 Introduction This document sets out the standards against which we, the General Pharmaceutical Council (GPhC), will accredit those
PL 17871/0208 UKPAR TABLE OF CONTENTS
Fultium-D 3 3,200 IU Capsules PL 17871/0208 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient
Combination Products Regulation in the United States
Combination Products Regulation in the United States Presenter: Scott Sardeson RAC US/EU 3M Health Care St. Paul, MN USA 1 Presentation Outline Combination products Definitions and Regulations Jurisdiction
EDUCATION PROGRAM 2012-2013
EDUCATION PROGRAM 2012-2013 It includes 2 modules: Module of academic course (obligatory): o 112 hours for the UD of the "Fundamentals in Medical Research" o 80 hours for the CRA "Clinical Research Assistant"
CTC Technology Readiness Levels
CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.
Journal of Chemical and Pharmaceutical Research
Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(2):892-898 World Health Organization s Guidelines for
A Stability Program for the Distribution of Drug Products
A Stability Program for the Distribution of Drug Products Teresa I. Lucas*, Rafik H. Bishara, and Robert H. Seevers Drug products must be transported in a manner that ensures products will be maintained
TGN 1412 Welche Änderungen haben sich für die Erstanwendung am Menschen aus Sicht des BfArM ergeben?
TGN 1412 Welche Änderungen haben sich für die Erstanwendung am Menschen aus Sicht des BfArM ergeben? PD Dr. med. Thomas Sudhop Bundesinstitut für Arzneimittel, Bonn Bundesinstitut für Arzneimittel IMP
POST-MASTER S CERTIFICATES in ADVANCED QUALITY ASSURANCE or REGULATORY AFFAIRS
Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 Phone: 267.468.8560 Fax: 267.468.8565 POST-MASTER S CERTIFICATES in ADVANCED QUALITY ASSURANCE or REGULATORY
Automating the Pharmacy Medication Cycle in Acute Care Settings
Automating the Pharmacy Medication Cycle in Acute Care Settings Costs, Benefits and Potential Unintended Consequences Enterprise Information Systems Steering Committee Nursing Informatics Committee and
Not All Clinical Trials Are Created Equal Understanding the Different Phases
Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact