Career opportunities for Ph.D. s in the pharmaceutical industry. Martin C. Michel, MD, MAE, FBPharmacolS
|
|
- Carmel Mitchell
- 7 years ago
- Views:
Transcription
1 Career opportunities for Ph.D. s in the pharmaceutical industry Martin C. Michel, MD, MAE, FBPharmacolS
2 Disclaimer This presentation is intended to inform about career opportunities in the pharmaceutical industry in general; it is not intended to promote Boehringer Ingelheim as an employer. The job profiles and processes described here are based on those used by Boehringer Ingelheim. Other companies are likely to have similar job profiles and hiring processes, but may have different names for some of the functions described here.
3 Boehringer Ingelheim in brief Boehringer Ingelheim Center Our headquarters in Ingelheim, Germany Family-owned global corporation Founded 1885 in Ingelheim, Germany Focus on Human Pharmaceuticals, Animal Health and Biopharmaceuticals Total net sales: 14,065 million in 2013 Employees worldwide more than 47,000 R&D worldwide at five sites Expenses for R&D: 2,743 million (19.5% of revenue) 16 production facilities in 11 countries Affiliated companies: 142 worldwide Investment in tangible assets: 558 million 3
4 Who is Boehringer Ingelheim? Main areas of interest: Airway diseases Cardiometabolic diseases Oncology CNS diseases Immunology & Infectious diseases
5 Congratulations on your Ph.D.!
6 What s next? The ugly fact: In a system without net growth, by average each professor can only bring one of his/her trainees to reach the same career level but has more trainees than that Where do all the others go? The vast majority of PhD s will have to find long-term positions outside academia
7 Key messages Working in industry is not plan B Identify the career option that fits you, and then design your next steps to qualify in that direction
8 Aim of this presentation To create awareness of the multitude of career opportunities in the pharmaceutical industry and advice on how to get there Career opportunities also exist with other types of non-academic employers but are not covered here
9 Job characteristics: academia vs. industry Academia Self-driven, but do not underestimate institution/funder preferences High degree of independence and selfdetermination Often very specialized asdfadfasfd adsfa adsf Working in teams advantageous asdf asdf Limited vertical and even less horizontal career options Need to obtain external funding asdfa asdfa Reliable but moderate potential for salary development Job security? Industry Goal-driven, but do not underestimate own influence on goals Less independence and selfdetermination, but not by much Often generalist, specifically in higher functions Working in interdisciplinary teams a must More vertical and horizontal career options No need to obtain external funding, but internal funding also competitive Greater potential for salary development asf Job security?
10 Some of the many career options in industry Research & Development (Medicine & Medical Affairs) Pharmacovigilance Clinical Operations Production Operations Quality Assurance Drug Regulatory Affairs Licensing Publications management Medical Science Liaison Marketing & Sales Market Access and many others some not as entry level but via cross-functional moves within a company
11 Jobs in Research & Development Large segment of academic jobs in industry Target identification Drug discovery Lead optimization Formulations Pharmacokinetics Postdoc experience typically required Initial hiring often based upon highly specialized skills Often starting point to move to other functions
12 Jobs in Medicine & Medical Affairs Can have roles in clinical development or for marketed drugs Clinical development: design, analyze and report clinical phase I-III studies Marketed drugs: phase IV studies; handle internal and external medical information requests Postdoc experience typically required Medical background preferred, but PhD with general medical knowledge possible Clear orientation on applied research a plus for non-medical applicants
13 Jobs in Pharmacovigilance Establish and maintain database on safety and tolerability of drugs Analyzing adverse event pattern in clinical trials and spontaneous reports Generating reports for regulatory authorities on a regular basis Highly formalized processes, great attention to details required for patient safety Postdoc experience typically required If no medical background, at least general medical knowledge required Often as move within company
14 Jobs in Operations (clinical trial monitoring) Operations covers a wide range of functions Clinical trial organization and monitoring are important examples Formalized processes based on ICH and GCP guidelines Possibly heavy local/regional travel activity (site monitoring) Postdoc experience beneficial but not required If no medical background, at least general medical knowledge required
15 Jobs in Operations (Chemical and Pharmaceutical Production) Operations covers a wide range of functions Large scale synthesis of Active Pharmaceutical Ingredient (API) Improvement of route of synthesis Pharmaceutical manufacturing of the finished product Lifecycle management/improvement of existing formulations Quality control and quality assurance Supply of clinical trials with finished products Project management of cross functional activities Site monitoring of external partners, possibly heavy local/regional travel activity Formalized processes based on ICH and GMP guidelines Background in chemistry, pharmacy, chemical engineering etc. very often expected Postdoc experience beneficial but not required General medical knowledge beneficial
16 Jobs in Quality Assurance (QA) Monitor pharmaceutical quality of drug substance and drug product production and packaging process as well as analytics for starting materials, excipients, APIs, bulk and drug product Monitor and evaluate the validity of the different manufacturing steps as well as methods used Release of documentation like master batch records, testing specifications, stability programs, validation plans, Support during inspection and audits Postdoc experience typically required as chemist, pharmacist, technologist Background in analytical techniques beneficial as well as knowledge regarding registration and manufacturing cgmp, ICH guidelines, AMG, AMWHV. Knowledge
17 Jobs in Drug Regulatory Affairs Management of all regulatory aspects of pharmaceutical products throughout product lifecycle Development, implementation and adjustment of regulatory strategies during the development phases of the drug product lifecycle in accordance with current regulations and guidance Interaction with regulatory authorities for initial approval of new drugs and maintenance of existing registrations Coordination with preclinical, clinical, medical affairs manufacturing and quality systems groups Safeguarding of accuracy and quality of regulatory submissions Safeguarding of regulatory compliance to drug product label requirements Highly formalized processes Postdoc experience typically required, understanding of legal processes beneficial Often as move within company
18 Jobs in Licensing Networking with potential partners in industry, small companies and academia Coordination of scientific and commercial evaluation of opportunities for in- and out-licensing Handling of projects covering a broad range of indications within one or more therapeutic areas University degree, good general knowledge in life sciences preferably e.g. in biochemistry, biology, chemistry, medicine, pharmacology Understanding and knowledge of drug development and relevant patent, legal and commercial implications Analytical skills, business oriented, MBA of advantage Postdoc experience, in particular 3-5 years of industry practice or similar desired Often as move within company
19 Jobs in Publication Management Plan the publication strategy for a drug in close interaction with Medical Affairs, Clinical Development, Project Management, Statistics and other functions involved in the development of publications Timely execution of the publication plan by leading individual teams responsible for the delivery of a publication Interactions with external authors and medical writers Experience in clinical development, pharmaceutical industry and/or medical writing/publication management typically required Capability of strategic thinking as well as good project management skills are a plus Often as move within company or from external medical writing agency
20 Jobs as Medical Science Liaison Establishes and provides scientific expertise to support a region with product and disease state knowledge through individual and group presentations of scientific information Identifies and interacts with external experts through credible and accurate medical/scientific exchanges of information Contributes to continuous knowledge development of brand, competitors, disease state, and overall therapeutic knowledge Attends/participates in scientific congresses/meetings in Europe/Overseas in support of brand/entities No direct promotional activity! Typically a field-based function (up to 60% travel time) At least 2 years of medical and/or field experience in pharmaceutical industry Excellent communication and inter-personal skills Often as move within company
21 Jobs in Marketing & Sales Analyzing market potential, competitive environment, customers and stakeholders needs Creating and executing marketing and promotional strategy including forecasts and budgets Organizing sales force Sales representative can be an entry level function Postdoc experience not required Interest or even formal training in business function more relevant Often trainee function as entry level
22 Jobs in Market Access Analyze environment for market access in a given country and globally Includes Health Economics & Outcome Research Establish and implement strategies for market access and reimbursement Prepare value dossier demonstrating clinical and economic effectiveness of (new) products Can be MD, PhD, health economics or MBA background Interest or even formal training in business function more relevant Often trainee function as entry level (postdoc not required) Degree in Health Economics or relevant experience required to work in Health Economics & Outcomes Research Industry or consultancy experience required for other market access functions on global level Market access experts highly demanded in industry
23 What does this mean in practical steps? A post-doc period of a few years is a good way to broaden experience and deepen knowledge, even if you plan to work in a company later on Start thinking about where you wish to be 5 years down the road about 1 year prior to graduation or desired entry date Make specific plans about 6 months prior to graduation or desired entry date
24 Applying for a job Job requirements Most entry level positions for PhD s require post-doc experience Exceptions are jobs in Market Access and Marketing & Sales which often offer trainee programs Application process Open solicitations, i.e. independent of advertised job opportunities, are not promising For advertised jobs, apply to those which indeed match your qualification, experience and interest Few targeted applications are more promising (and less frustrating) than many untargeted applications Informal inquiries via an internal contact in the target company can be helpful
25 A piece of personal advice The University of Duisburg-Essen (similar to some others) offers an MSc program in Pharmaceutical Medicine 2 year program with national and international accreditation Targeted at junior company employees and those wishing to find a job in industry Largely self-study with 1 weekend per month face time Covering entire value chain from target discovery to marketing Taught by practitioners in the field from 18 different companies and regulatory authorities (BfArM) >90% of graduates within 1 year got a promotion or found a job in industry Application is open for the next program starting April 2015 at
26 Good luck!
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
More informationSalary Survey 2014. Domestic, International Salary Survey and Country Cost Analysis
Salary Survey 2014 Domestic, International Salary Survey and Country Cost Analysis Disclaimer: This salary guides contained herewith have been constructed to represent average salaries across a range of
More informationIs 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
More informationOverview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience
ICH and Singapore Dr Christina Lim Deputy Group Director, Health Product Regulation Group Senior Advisor, International Collaboration Health Sciences Authority Singapore November 2008 Overview Health Science
More informationThe Quality System for Drugs in Germany
The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute
More informationSession 6: WHO Prequalification Programme. Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs
Session 6: WHO Prequalification Programme Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs Session adapted from the WHO training workshop on prequalification and the WHO technical briefing seminar
More informationMINISTRY 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
More informationRegulatory Affairs Graduate & Postgraduate Program. Novartis Pharma AG Novartis Animal Health AG
Regulatory Affairs Graduate Postgraduate Program Novartis Pharma AG Novartis Animal Health AG The Regulatory Affairs (RA) Graduate Program is an opportunity to discover the global functions of Drug Regulatory
More informationPharmaceutical Sciences
Is a Career in the Pharmaceutical Sciences Right for Me? Check out our online Student Center to find out more: www.aapspharmaceutica.com/students How do I know if a career in the pharmaceutical sciences
More informationTHE BIOTECH & PHARMACEUTICAL INDUSTRY
THE BIOTECH & PHARMACEUTICAL INDUSTRY ESSENTIAL CAREERS INFORMATION CALUM LECKIE KATIE BISARO CAREERS CONSULTANTS What we will cover Sector overview Types of role Graduate recruitment trends and issues
More informationThe agency perspective
The agency perspective 16 January 2014 Anna Palmer Scientific Services Manager Contents What is medical communications? How did I get here? Medical communications vs other agencies What do we actually
More informationPOST-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
More informationGMP 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
More informationSchool 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
More informationBachelor of Science in Pharmaceutical Sciences (BSPS) Program Overview and Internship Requirements
Bachelor of Science in Pharmaceutical Sciences (BSPS) Program Overview and Internship Requirements Pharmaceutical Sciences Applied sciences that underlie the practice of pharmacy the development, manufacture,
More informationMasters Learning mode (Форма обучения)
Program Title (Название программы): Pharmacology Degree (Степень) Masters Learning mode (Форма обучения) Full-time and part-time Duration of study (Продолжительность программы) 2 years (4 years part time)
More informationHow To Understand The Pharmacology Of The Pharmaceutical Industry
It; MM MODERN Ul NDUSTRY 77 /
More informationBrand Quality with Asian Advantages
Brand Quality with Asian Advantages ScinoPharm Taiwan, Ltd. No.1, Nan-Ke 8th Road, Tainan Science Park, Shan-Hua, Tainan, 74144, Taiwan TEL : 886-6-505-2888 FAX : 886-6-505-2898 Email Contact : mkt@scinopharm.com
More informationNEW 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
More informationDrug Information Journal, Vol. 33, pp. 755 761, 1999 0092-8615/99
Drug Information Journal, Vol. 33, pp. 755 761, 1999 0092-8615/99 Printed in the USA. All rights reserved. Copyright 1999 Drug Information Association Inc. THE ACTIVE PHARMACEUTICAL INGREDIENTS STARTING
More informationWorking in industry. Jon Day BSc(hons), PhD, FSB, CBiol
Working in industry Jon Day BSc(hons), PhD, FSB, CBiol Presentation overview Aims and objectives Who am I? Who are you? Deciding whether to work in industry Transferable skills Career paths Routes of entry
More informationICH Q7 GMP for Active Pharmaceutical Ingredients
National University of Singapore Academy of GxP Excellence (NUSAGE) and PharmEng Technology Presents ICH Q7 GMP for Active Pharmaceutical Ingredients Part of the Pharmaceutical Biotechnology Training Courses
More informationThe Main Challenges around IDMP 1 and Ways to Solve Them. Article by Dieter Schlaps, IT Consulting Life Science, Wessobrunn, Germany
The Main Challenges around IDMP 1 and Ways to Solve Them Article by Dieter Schlaps, IT Consulting Life Science, Wessobrunn, Germany Abstract: As of 1 July 2016, pharmaceutical companies which develop and
More informationC 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
More informationOversight of Clinical Trials in Europe - Member State perspective. Gunnar Danielsson Senior Expert Pharmaceutical Inspector
Oversight of Clinical Trials in Europe - Member State perspective Gunnar Danielsson Senior Expert Pharmaceutical Inspector Oversight of Clinical Trials Oversight of clinical trials occur on many different
More informationBachelor s Degree. in Manufacture of Medicinal Products (DT291) Full Time Part Time Online. www.getreskilled.com
Bachelor s Degree in Manufacture of Medicinal Products (DT291) Full Time Part Time Online www.getreskilled.com Contents 1. Welcome 2. Program Overview 3. Program Content 4. Core Modules 5. Optional Modules
More informationHaving 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
More informationPharmD Postdoctoral Fellowship Program
Novartis Institutes for Biomedical Research and Massachusetts College of Pharmacy and Health Sciences, Worcester/Manchester PharmD Postdoctoral Fellowship Program Introduction Fellowship training in the
More informationWorking 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
More informationMedical Information Role in the Pharmaceutical Industry
www.arisglobal.com A White Paper Presented By ArisGlobal Medical Information Role in the Pharmaceutical Industry by Ome Ogbru, PharmD, Medical Information, SME What is Medical Information Overview Medical
More informationFLORIDA A&M UNIVERSITY AND BRISTOL-MYERS SQUIBB PHARMACEUTICAL INDUSTRY RESIDENCY PROGRAM 2015-2016
FLORIDA A&M UNIVERSITY AND BRISTOL-MYERS SQUIBB PHARMACEUTICAL INDUSTRY RESIDENCY PROGRAM 2015-2016 TABLE OF CONTENTS Dear Prospective Residents.........................................................
More informationAnnex 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
More informationA 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
More informationPHARMACEUTICAL INDUSTRY Fellowship Program
PHARMACEUTICAL INDUSTRY Fellowship Program USC School of Pharmacy 2015-2016 In partnership with ABOUT OUR COMPANY Allergan, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company
More informationAnnex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70
Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initiating
More informationProcess Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation)
Global CompliancePanel Knowledge, a Way Forward 2-day In-person Seminar: Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) Los Angeles, CA July 28th & 29th, 2016
More informationHistory and Principles of Good Clinical Practice
History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices
More informationSystematic Drug Repurposing: Some Successes, Caveats, and Directions
Systematic Drug Repurposing: Some Successes, Caveats, and Directions Christopher P. Austin, M.D. Director, Division of Preclinical Innovation National Center for Advancing Translational Sciences National
More informationPL 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
More informationAssociate Group Director, Regulatory Intelligence & Policy
Date: 06/24/16 Associate Group Director, Regulatory Intelligence & Policy Job ID: 2974410847 Job Function Project Management Regulatory Affairs Location United States - District of Columbia Washington
More informationPHARMACEUTICAL QUALITY SYSTEM Q10
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step
More informationTRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP
DISCLAIMER: The EU reserves the right to make subsequent modifications to this text and to complement its proposals at a later stage, by modifying, supplementing or withdrawing all, or any part, at any
More informationImporting 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
More informationExtemporaneously Prepared Early Phase Clinical Trial Materials
Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development
More informationEventuale spazio per nome struttura o altro. Pharmacy education. The Italian academic viewpoint
Eventuale spazio per nome struttura o altro Pharmacy education. The Italian academic viewpoint Faculty of Pharmacy Total number of Pharmacy higher education institutes in Italy 1. Faculty of Pharmacy,
More informationQUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES
QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES Why are Pharmacopoeias so important in a globalised world? Pharmacopoeias have historically provided collections of medical recipes intended to ensure accurate
More informationCourse Certificate In. Pharmaceuticals and Medical Research: Clinical Research Monitoring & Coordination
Course Certificate In Pharmaceuticals and Medical Research: Clinical Research Monitoring & Coordination Welcome to the latest in distance learning courses designed to prepare you, on your own schedule,
More informationEXPERT 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
More informationRAPS ONLINE UNIVERSITY
RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.
More informationA NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program
A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry CLEANING VALIDATION Instructors Loh Kean Chong Rick Ng Date and Time
More informationPharmaceuticals 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
More informationGraduate Education in Pharmacy Schools: Pharmacy Administration
Graduate Education in Pharmacy Schools: Pharmacy Administration Developed by: Noel E. Wilkin, R.Ph., Ph.D. Associate Provost Associate Professor, Department Chair: Donna West, RPh, PhD Associate Professor,
More informationU.S. Bureau of Labor Statistics. Pharmacy Tech
From the: U.S. Bureau of Labor Statistics Pharmacy Tech Pharmacy technicians fill prescriptions and check inventory. Pharmacy technicians help licensed pharmacists dispense prescription medication. They
More informationAnnex 7 Guidelines for the preparation of a contract research organization master file
World Health Organization WHO Technical Report Series, No. 957, 2010 Annex 7 Guidelines for the preparation of a contract research organization master file Background 1. General information 2. Quality
More informationThe Role of Regional Medical Advisor (RMA)-Field Medical. Dr. Aju Abraham Varghese Pfizer India. Feb 22 nd 2014
The Role of Regional Medical Advisor (RMA)-Field Medical Dr. Aju Abraham Varghese Pfizer India Feb 22 nd 2014 Disclaimer The opinions expressed in this presentation are solely those of the presenter and
More informationCTC 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.
More informationIndustry Implications of Pharmaceutical Quality ICH Guidelines
EIPG General Assembly Industry Implications of Pharmaceutical Quality ICH Guidelines 20 th April 2008 Pharmaceutical Quality Develop a harmonised pharmaceutical quality system applicable across the lifecycle
More informationDEPARTMENT OF CHEMISTRY
DEPARTMENT OF CHEMISTRY Brandon University Department of Chemistry Faculty of Science Phone (204) 727-9677 Fax (204) 728-7346 This document is meant as a planning guide only. Students are advised to consult
More informationCertified National Pharmaceutical Representative
Certified National Pharmaceutical Representative 120 hours Course Overview/Description The Certified National Pharmaceutical Representative (CNPR) online training program was developed in partnership with
More informationPost-Doctoral Pharmaceutical Industry Fellowships. Two-Year Clinical Development Program Two-Year Clinical Safety Program
Post-Doctoral Pharmaceutical Industry Fellowships Two-Year Clinical Development Program Two-Year Clinical Safety Program Today, we innovate by creating new medicines, as well as new methods of drug discovery
More informationProgramme Name: Post-Baccalaureate Doctor of Pharmacy (Pharm. D) Programme Code: PPHPHARPT
Graduate Education Courses of Study in the College of Health Sciences The College of Health Sciences currently offers 4 Graduate courses of study namely: Post Baccalaureate Doctor of Pharmacy (Pharm. D),
More informationWhat We Are..! www.ardent-cro.com
Your Trusted CRO! Regus, Level-2, Connaught Place, Bund Garden Road, Pune-411001, MH, India. Phone: 020-65-31-31-71 Email: ardent@ardent-cro.com Web: What We Are..! Ardent Clinical Research Services is
More informationFDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY
SMG 1312.4 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY OFFICE OF REGULATORY AFFAIRS OFFICE OF OPERATIONS
More information2009 Foley & Lardner LLP Attorney Advertising Prior results do not guarantee a similar outcome Models used are not clients but may be representative
Attorney Advertising Prior results do not guarantee a similar outcome Models used are not clients but may be representative of clients 321 N. Clark Street, Suite 2800, Chicago, IL 60654 312.832.4500 Life
More informationCareer Management: Making the most of your MCF
Career Management: Making the most of your MCF Anne Forde, Careers Adviser for Life Science Postdocs, University of Cambridge Career Management for MCFs Career management: Why plan? Planning route A, and
More informationGuidance for Industry. Q10 Pharmaceutical Quality System
Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation
More informationMBA. Master. Market Access. Part-time berufsbegleitend. Pharmacovigilance. Strategic Management. Regulatory Affairs.
master of Pharma BUSINESS ADMINISTRATION MBA Part-time berufsbegleitend Master of Pharma BUSINESS ADMINISTRATION Health Economics Corporate Finance Strategic Management Regulatory Affairs Production Market
More informationRegulations 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
More informationDrug Development Process
Drug Development Process Original Arthur: Addie D. Anderson CRB Consulting Engineers, Inc. Overview Important milestones establishing our current system of regulations Step-by-step overview of the drug
More informationHarmonizing Change Control Processes Globally
Quality & Compliance Associates, LLC Harmonizing Change Control Processes Globally President Quality & Compliance Associates, LLC When We Deal In A Global Environment, How Do We Design A System That Addresses
More informationThe majority of pharmaceutical companies in
Pharmaceutical Infrastructure and Industry Professor Che-Ming Teng, Ph.D. National Taiwan University College of Medicine, Taipei, Taiwan The majority of pharmaceutical companies in Taiwan are devoted to
More informationThe objectives of the Sri Lankan National Medicinal Drug Policy are
NATIONAL MEDICINAL DRUG POLICY FOR SRI LANKA Preamble Sri Lanka had a partly written Drug Policy from the 1960s. It was written as elements of a policy, beginning from selection of drugs for the government
More information2014 Annual Report on Inspections of Establishments
2014 Annual Report on Inspections of Establishments Table of Contents Introduction... 2 Data Collection and Definitions... 3 Section 510(h)(6)(A)(i) Number of Domestic and Foreign Establishments Registered
More informationASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE
ASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE THIS POLICY OUTLINES THE TOP LEVEL REQUIREMENTS TO SUPPORT PRODUCT QUALITY IN THE DEVELOPMENT, MANUFACTURE AND DISTRIBUTION OF ACTIVE PHARMACEUTICAL
More informationICH guideline Q10 on pharmaceutical quality system
September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final
More informationAnnex 3 Procedure for prequalification of pharmaceutical products
World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 3 Procedure for prequalification of pharmaceutical products 1. Introduction 2. Glossary 3. Purpose and principles 4. Steps of
More informationVeterinary Compounding
Veterinary Compounding Veterinarians occasionally use compounded preparations to meet a specific patient s medical need. The purpose of this brochure, created jointly by the Animal Health Institute (AHI),
More informationMBA. Master. Market Access. Part-time berufsbegleitend. Pharmacovigilance. Strategic Management. Regulatory Affairs.
master of Pharma BUSINESS ADMINISTRATION MBA Part-time berufsbegleitend Master of Pharma BUSINESS ADMINISTRATION Health Economics Corporate Finance Strategic Management Regulatory Affairs Production Market
More informationMSc in Toxicology. Master Degree Programme
Master Degree Programme MSc in Toxicology Department of Pharmaceutical Sciences, University of Basel Swiss Centre for Applied Human Toxicology (SCAHT) Master of Science in Toxicology University of Basel
More informationMedical Writing. What is medical writing? What qualifications and skills do I need?
European Medical Writers Association Medical Writing Ever thought about medical writing as a career? If you want to get away from scientific research, but still use your scientific knowledge and skills,
More informationMedical Science Liaison (MSL): Understanding, Engaging and Interacting. Gill Logan Regional Medical Affairs Manager Takeda UK
Medical Science Liaison (MSL): Understanding, Engaging and Interacting Gill Logan Regional Medical Affairs Manager Takeda UK Date of upload, October 2011 Disclosures Takeda UK employee Member of the MSLA
More informationMSC IN MEDICINAL CHEMISTRY
faculty of health and medical sciences university of copenhagen MSC IN MEDICINAL CHEMISTRY det sundhedsvi københavns univer Master s programme at the University of Copenhagen msc in medicinal chemistry
More informationCareers in Medical and Scientific Writing
Careers in Medical and Scientific Writing Laura McCormick, PhD Vice President Associate Practice Leader Tamara Fink, PhD Associate Scientific Director ProEd Communications, Inc Beachwood, Ohio Agenda Introduction
More informationAP Recruit: Basic Qualifications
AP Recruit: Basic Qualifications Purpose/Background Definition Practice Reviewing Job Aid 1 UCSF is a Federal Contractor UCSF ranked 2 nd in the Top 5 Recipients of NIH Research Grants in 2012 Federal
More informationJob Profile Clinical Research Associate III (CRA)
PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed
More informationOverview of Pre-Approval Inspections
Overview of Pre-Approval Inspections Presented by: Kelli F. Dobilas NWJ-DO Pre-Approval Manager Pre-Approval Drug Inspections What are Pre-Approval Inspections? One of the last reviews of the drug approval
More informationPharmaceutical Quality Systems: US Perspective
Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical
More informationThe Board reviews risks to the Company s business plan at its scheduled meetings.
Pharmaxis Ltd 1. Board responsibility The Pharmaxis Board is responsible for ensuring the Company establishes and maintains a risk management framework for the oversight and management of risk. The Board
More informationQuality by Design Concept
3rd Jerusalem Conference on Quality and Pharma Sciences 6-7 June, 2012 QbD in Clinical Research - Where Can QbD Impact Clinical Research Practices? Dr. Yafit Stark Vice President, TEVA Pharmaceutical Industries,
More informationBIOLOGICAL SCIENCES. What can I do with this degree?
AREAS BIOLOGICAL SCIENCES What can I do with this degree? EMPLOYERS STRATEGIES BIOTECHNOLOGY Laboratory Testing GENETICS related to: Animals Plants Humans Genetic Counseling MICROBIOLOGY Agricultural industry
More informationA NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program
A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry PROJECT MANAGEMENT: RENOVATION OF RESEARCH LABORATORY FOR CELL CULTURE
More informationRoles & Responsibilities of the Sponsor
Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from
More informationWorkshop B Control Strategy
ICH-GCG ASEAN Workshop B Control Strategy Jean-Louis ROBERT, Ph.D. National Health Laboratory, Luxembourg Chair-person ICH IWG Q8, Q9, Q10 Kuala Lumpur, 26-28 July 2010 International Conference on Harmonisation
More informationTemple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034. Phone: 267.468.8560 Fax: 267.468.
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 CERTIFICATE in CLINICAL TRIAL MANAGMENT Designed for Pharmaceutical
More informationMCPHS University and Pfizer. Biopharmaceutical Industry Fellowship Program
MCPHS University and Pfizer Biopharmaceutical Industry Fellowship Program Fast Facts Location : Groton, Connecticut Fellowship Programs Global Clinical Supply : Quality Assurance Length : Two years Requirements
More informationComparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance
More informationRegulatory Expectations for GMP: What s Happening. Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc.
Regulatory Expectations for GMP: What s Happening Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc. Topics Background for changes and expectations of regulatory
More informationAn 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
More informationDZIF-Product Development Unit (PDU)
November 29, 2013 7 th International VPM Days DZIF-Product Development Unit (PDU) - DZIF-TPMO at HZI - DZIF-OSRA at PEI Thomas Hesterkamp, Helmholtz Zentrum für Infektionsforschung Support from TPMO &
More information