FUTURE MEANS CREATIVITY
|
|
- Sharleen Nelson
- 6 years ago
- Views:
Transcription
1 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 1 EARLY PHASE DRUG DEVELOPMENT COURSE MAY 9 TH ANTWERP FUTURE MEANS CREATIVITY VENUE: LINDNER HOTEL LANGE KIEVITSTRAAT 125 BE-2018 ANTWERP, BELGIUM SPONSORED BY:
2 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 2 This course aims to provide participants with a strong insight in how drugs are developed, and how you can successfully make the transition from lab to clinic. This meeting encompasses a theoretical plenary morning session with expert lectures and discussions, and in the afternoon, practical workshops where the participants will apply the lessons learned on actual case studies. This meeting will address: The common hurdles and challenges in early phase drug development Which regulatory aspects you need to take into account when moving through the different phases of drug development How early data analysis through pharmacokinetic and modeling & simulation can optimize decision making AGENDA 9:00-9:30 REGISTRATION AND WELCOME COFFEE 9:30 OPENING 09:35-10:20 OPTIMIZING EARLY CLINICAL DRUG DEVELOPMENT IN THE 21 ST CENTURY Dr. Katrien Lemmens Medical Director Early Phase 10:20-11:05 HOW CLINICAL PHARMACOLOGY AND PHARMACOKINETICS EXPERTISE CAN SUPPORT THE EARLY CLINICAL DEVELOPMENT OF NEW DRUGS: FROM THEORY TO PRACTICE Nariné Baririan PK and Clinical Pharmacology Expert 11:05-11:15 COFFEE BREAK 11:15-12:00 INFORMED DECISIONS FOR TARGET SELECTION: HOW CAN PK/PD MODELING & SIMULATION CONSULTANCY HELP? Ruben Faelens Scientist Exprimo 12:00-12:45 FROM LAB TO MARKET: WHAT DO REGULATORS EXPECT? Bruno Speder Head Clinical Regulatory Affairs & Consultancy 12:45-13:30 LUNCH BREAK 13:30-14:30 WORKSHOPS & CASE STUDIES 14:30-14:50 COFFEE BREAK 14:50-16:00 CONCLUSION & CLOSING The venue is the Linder Hotel in Antwerp (Kievitplein, 2000 Antwerp), conveniently located near the Antwerp Central Railroad station. The hotel also has a car park, located in the Van Immerseelstraat. Lunch and refreshments throughout the day are foreseen. The training is free of charge, however registration is mandatory. Register yourself by sending an to Christina.Abts@sgs.com before 1 May. A certificate of attendance will be provided to the participants.
3 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 3 SPEAKER S & BIOGRAPHIES OPTIMISING EARLY CLINICAL DRUG DEVELOPMENT IN THE 21 ST CENTURY DR. KATRIEN LEMMENS Medical Director Early Phase Over the past three decades, costs of drug development have risen sharply, while the likelihood for a new compound to make it to the market declined. This discrepancy reveals the need to rethink the traditional clinical development model. Recent advances in science and technology pave the way for sophisticated and innovative approaches. For example, better understanding of diseases at the molecular level leads to the development of molecularly targeted therapies. Also, a patient s response to treatment in terms of safety and efficacy can be better predicted upon their molecular and genetic profile. This presentation focuses on the critical role of the early clinical development process. Modernizing and optimizing early phase clinical studies is paramount for late phase success. Therefore, early phase clinical trials, such as the first-in-human trials, need to be designed in a smart way to gain crucial information on the new compound as early as possible. Implementing innovative tools, such as biomarkers, aids to improve safety/efficacy testing methods and provides the possibility to improve success rates and shorten timelines. During the workshop, a practical exercise will be provided to reflect on possible tools and designs that can be used to optimize the trial. Dr. Lemmens obtained her MD in 2000, and a PhD in 2006 from the University of Antwerp. She started her medical career as a clinical cardiologist, before undertaking a post-doctoral position at the physio-pharmacology laboratories at the University of Antwerp. Dr. Lemmens went on to join Janssen Pharmaceuticals where she was Medical Director of its Clinical Pharmacology Unit in Merksem, before rejoining the University of Antwerp as Associate Professor of Pathophysiology and Pharmacology. From Oct 2016, Dr Lemmens joined as Medical Director Early Phase. HOW CLINICAL PHARMACOLOGY AND PHARMACOKINETICS EXPERTISE CAN SUPPORT THE EARLY CLINICAL DEVELOPMENT OF NEW DRUGS: FROM THEORY TO PRACTICE NARINÉ BARIRIAN, PK and Clinical Pharmacology Expert Animal and other forms of laboratory research provide the foundation for human studies. Before proceeding to early human testing, investigators and reviewers must determine whether the preclinical scientific foundation is adequate. This is a complex and valueladen task. First in Human (FIH) clinical trials are part of the exploratory phase of drug development and represent a significant milestone in the clinical development of new drugs. When only preclinical data are available to guide dose-selection, population, study design, safety monitoring and appropriate expertise are all critical to maximise the safety of the study subjects and the quality of the data. In choosing design options for FIH and other Early Phase clinical trials, it is important to consider factors linked to the compound pharmacological (PK and PD) characteristics. This presentation will discuss how Clinical Pharmacology and Pharmacokinetics expertise are crucial to find the best clinical trial design which will be acceptable for appropriate Health Authorities and will bring valuable results. Some practical examples of drug-drug interaction and hepatic/renal impairment study designs will be discussed during the workshop.
4 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 4 After obtaining a University degree in Pharmaceutical Sciences, Nariné has started the Research Master in UCL (Belgium) in Cellular and Molecular Pharmacology orientation. The research experience was continued by a PhD in Pharmaceutical Sciences at UCL and St Luc Hospital (Bruxelles) in Clinical Pharmacology and Pharmacokinetics orientation. By doing PhD, Nariné performed her own research clinical trials in the Unité de Pharmacologie Clinique at St Luc Hospital and therefore obtained the first knowledge and experience in Clinical Pharmacology applied to Clinical Trials, which was further continued at. 10 years ago Nariné joined as Pharmacokineticist, then she worked as a PK team Coordinator and now as PK and Clinical Pharmacology Expert. In her function, Nariné is a part of consultancy/experts team supporting/advising the clients in the study designs and Clinical Development plans of their new compounds. INFORMED DECISIONS FOR TARGET SELECTION: HOW CAN PK/PD M&S CONSULTANCY HELP? RUBEN FAELENS Scientist Exprimo In this talk, Ruben Faelens from Exprimo will show how we can make better decisions in drug development, through the use of Modeling & Simulation. Strategic decisions in drug development can be of vital importance to a company. In , the Likelihood of Approval from Phase 1 was only 9.6%. Only 1 in 10 promising drugs get approved for use in humans. The attrition rate for Phase 2 is the highest, with 69.3% of Phase II trials failing. To fix this, we need to make better decisions. We need better information. Authorities agree, and promote Model-Informed Drug Development as one of the tools to discover early on if compounds will fail in later phases. In this talk, we present a concrete case study for Phase 2 trial design in Parkinson s Disease. Using publicly available information, we show how we designed the study, and how we optimized information discovery during the trial. Afterwards, a practical session will allow you to simulate several trial design options for yourself, using a demo compound. Together, we will decide the next step for your compound, allowing you the best chances of market approval. Ruben is a Scientist at Exprimo. He obtained a Master s degree from the KULeuven (Belgium) in Computer Science in He also studied abroad in Stockholm (Sweden) for 6 months. Ruben joined Altran, a software consultancy firm, in late There, Ruben was involved in the development of business software for (primarily) pharmaceutical companies as the lead of a team of programmers. This allowed him to become acquainted with a variety of subjects: pharmacoeconomics, pharmacometrics, production planning for oil fields, HR planning, failure testing of engine components and simulation of distributed heating plants. In September 2013, Ruben joined ONE Agency as a Technical Sales and Bid Manager. In March 2014, Ruben joined Exprimo, where he can combine his strong interest in the field of pharmacometrics with his passion for IT. Ruben focuses on simulation projects (clinical trial optimization, power calculation, therapeutic drug monitoring), as well as the internally developed pharmacometric simulation software.
5 START-UP & ACADEMICS THEORY & PRACTICE IN DRUG DEVELOPMENT 5 FROM LAB TO MARKET: WHAT DO REGULATORS EXPECT? BRUNO SPEDER, Head Clinical Regulatory Affairs & Consultancy Bringing a compound from the lab to the market is a long and winding road with a great number of potential pitfalls. During drug development it is very important to have a clear view on the expectations of Regulatory Authorities at each stage of drug development. During this talk we will highlight the most common regulatory issues that may arise through a number of illustrated case studies and how you can make sure you keep your development on track. Bruno is Head Clinical Regulatory affairs & Consultancy at Clinical Research. Bruno is pharmaceutical engineer and has almost 10 years experience in drug development. He supports pharmaceutical and biotech companies in designing their regulatory strategies and supports them in the interactions with regulators like EMA and FDA. He is member of the advisory board of several biotech companies and guest lectures on clinical research in the honours Program of the Ghent University. He is also member of the clinical trial steering group of TOPRA, the European Organisation for Regulatory Affairs. ABOUT LIFE SCIENCES is a leading life science CRO providing clinical research, biologics characterization, biosafety, and quality control testing. Delivering solutions in Europe and in the US, provides clinical trial management (Phase I to IV) services encompassing clinical project management and monitoring, data management, biostatistics, medical writing, pharmacovigilance, PK/PD Modeling & simulations and regulatory consultancy. has its own clinical unit with a total of 88 hospitalization beds in Belgium and has a wealth of expertise in FIH studies, human viral challenge testing, biosimilar and complex PK/PD trials, as well as other regulatory and exploratory trials. has a large database of investigators and key opinion leaders with therapeutic focuses in Infectious Disease, Vaccines, Oncology, and Respiratory. CONTACT US VENUE ADDRESS CONTACT COST & ACCOMMODATION Lindner Hotel Lange Kievitstraat 125 BE-2018 Antwerp, Belgium Christina Abts Christina.Abts@sgs.com The seminar is offered free of charge. However, only pre-registered attendees will be admitted.
6 Group Management SA 2017 All rights reserved - is a registered trademark of Group Management SA
4th ANTWERP BIOPHARM DAY SAFETY & EFFICACY CLINICAL TRIALS SOLUTIONS DATE: OCTOBER 29, 2015
4th ANTWERP BIOPHARM DAY SAFETY & EFFICACY CLINICAL TRIALS SOLUTIONS DATE: OCTOBER 29, 2015 VENUE: LINDNER HOTEL LANGE KIEVITSTRAAT 125 BE-2018 ANTWERP, BELGIUM 2 Join the 4 th one-day seminar to discuss
More informationEARLY DRUG DEVELOPMENT CONSULTANCY & SERVICES CLINICAL RESEARCH SOLUTIONS
EARLY DRUG DEVELOPMENT CONSULTANCY & SERVICES CLINICAL RESEARCH SOLUTIONS As a full service contract research organisation performing phase I to IV clinical trials across Europe and the Americas for 40
More information395 South Youngs Road Buffalo, New York cognigencorp.com An On-Site 2-Day Workshop in Engineering The Pharmacometric Enterprise
395 South Youngs Road Buffalo, New York 14221 716.633.3463 cognigencorp.com An On-Site 2-Day Workshop in Engineering The Pharmacometric Enterprise A Workshop For Improving the Efficiency and Effectiveness
More informationRole of Academic Investigators in Drug Development
DTRCS Regulatory Education Seminar, June 12, 2007 Role of Academic Investigators in Drug Development Howard Lee, MD, PhD Associate Adjunct Professor Director, Center for Drug Terminology Sponsor Investigator
More informationHUMAN CHALLENGE TESTING
HUMAN CHALLENGE TESTING CLINICAL RESEARCH SOLUTIONS DE-RISKING Faced with increasing pressures on timelines and budgets, clinical research practices need to continuously evolve in order to ensure pipeline
More informationMODEL-BASED DRUG DEVELOPMENT: A FDA CRITICAL PATH OPPORTUNITY
MODEL-BASED DRUG DEVELOPMENT: A FDA CRITICAL PATH OPPORTUNITY Donald R. Stanski MD Scientific Advisor, Office of the Commissioner, FDA Professor of Anesthesia Stanford University, CA THE OPINIONS EXPRESSED
More informationBIOMETRICS SERVICES ADVISORY DATA OFFICE UNBLINDING SECURE INDEPENDENT TEAM PROGRAM. ADaM TRAINER SAFETY SDTM COMPLIANT TA-EXPERTISE SDTM DATA
BIOMETRICS SERVICES DELIVER UNBLINDED DATASETS TO IDMC SDTM-IG UNBLINDING ADVISORY QUALITY ON TIME DEDICATED DATA SECURE BOARD EMERGENCY PARTNERSHIPTEAM DATA OFFICE UNBLINDING INVESTINGEXPERTISE SHARING
More informationEarly Phase Education WHITEPAPER. Three major items to consider when moving from preclinical to clinical development
Early Phase Education WHITEPAPER Three major items to consider when moving from preclinical to clinical development Three major items to consider when moving from preclinical to clinical development Dr.
More informationMedical Affairs for Modern Pharma New Challenges & Competencies
2-Day Course Medical Affairs for Modern Pharma New Challenges & Competencies Learn how medical affairs can enhance the commercial success of pharma brands with market insight generation, brand value definition,
More informationBuilding a Career in the Pharmaceutical Industry: Personal Reflections. Carlo Nalin, PhD Executive Director Novartis Oncology
Building a Career in the Pharmaceutical Industry: Personal Reflections Carlo Nalin, PhD Executive Director Novartis Oncology 2 Career Development: Personal Reflections C Nalin 5 April 2016 Cornell BEST
More informationClinical Development and enabling Regulatory Steps: How to obtain ODD and Scientific Advice at EMA
Clinical Development and enabling Regulatory Steps: How to obtain ODD and Scientific Advice at EMA TELETHON Convention, Riva del Garda (TN) 15 March 2017 Michela Gabaldo Head Alliance Management & Regulatory
More informationOrganized by Department of Statistics. Date: September 8, 2018 Venue: Hotel Crowne Plaza. An Event by
Organized by Department of Statistics An Event by Date: September 8, 2018 Venue: Hotel Crowne Plaza Sarkhej - Gandhinagar Highway, Near Shapath V, Prahlad Nagar, Ahmedabad, Gujarat, India Department of
More informationGet started with HTRF
Get started with HTRF A training program for academic researchers and students François Degorce, Fabienne Charrier- Savournin Context and objectives Who never used an ELISA or a Western Blot in a biology
More informationSubgroups along the development axis
Paper PD03 A dedicated Programming Group working in a pharmaceutical Modeling & Simulation organization Vincent Buchheit, Novartis, Basel, Switzerland 1. ABSTRACT Modeling and Simulation (M&S) emerges
More informationA drug development crossroad lies ahead
G L O B A L C B O C O S T E F F E C T I V E B I O A N A L Y T I C A L H I G H Q U A L I T Y E A R L Y S T A G E C L I N I C A L T R A N S L A T I O N A L M E D I C I N E H I G H L Y C O M P E T E N T A
More informationAgreed with W. Cornell Graduate Program and Tri-I
Drug Development Course From Molecule to Prescription Weill Cornell Graduate School - Tri-Institutional Therapeutics Discovery Institute ABOUT THIS COURSE This course has been designed in collaboration
More informationAddressing challenges in Drug Development and Quality Control with innovative solutions
Addressing challenges in Drug Development and Quality Control with innovative solutions SYNOPSIS 16 May 2013, 9:30 am 3:00 pm Gd. Titan Centre (Theater Room) This seminar is designed for scientists in
More informationMODULE 12 Regulatory affairs April 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES
MODULE 12 Regulatory affairs 26-27 April 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES n DRUG REGISTRATION : EUROPEAN PROCEDURES AND INTERNATIONAL ENVIRONMENT
More informationSHORT COURSE. Practical Considerations for Biomarker Bioanalysis: Scientific and Regulatory Perspective SUNDAY, SEPTEMBER 17
SHORT COURSE SUNDAY, SEPTEMBER 17 OMNI PROVIDENCE HOTEL PROVIDENCE, RI Practical Considerations for Biomarker Bioanalysis: Scientific and Regulatory Perspective SPONSORED BY: Organized by: www.bostonsociety.org
More informationClinical Data Management 2.0: Madrid, Spain. Fundamentals and New Skills of today s Clinical Data Manager. Thursday, 10th May :00 18:00
A CROS Academy course Thursday, 10th May 2018 9:00 18:00 Clinical Data Management 2.0: Madrid, Spain For further information: Secretarial office EasyB Srl email crosacademy@crosnt.com Ph. +39(0)35.4123594
More informationIssues in Cancer Drug Development of the Future. Janet Woodcock M.D. Deputy Commissioner/Chief Medical Officer, FDA October 5, 2007
Issues in Cancer Drug Development of the Future Janet Woodcock M.D. Deputy Commissioner/Chief Medical Officer, FDA October 5, 2007 Agenda: Scientific Issues n Why improve the quality of cancer clinical
More informationAmerican Association of Pharmaceutical Scientists (AAPS)
American Association of Pharmaceutical Scientists (AAPS) AAPS, King Street, Alexandria, VA, USA* he American Association of Pharmaceu- Scientists (AAPS), founded in 1986, Ttical is an individual membership
More informationBelgium, a European leader in clinical trials
Belgium, a European leader in clinical trials An attractive country for clinical trials to test innovative medicines In Europe it is nearly impossible to find other countries with as many clinical trials
More informationIDSA is pleased to offer the following comments on specific priority areas identified by FDA:
October 31, 2018 Shashi Malhotra Office of Acquisitions & Grants Services (OAGS) Food and Drug Administration Telephone: 240-402-7592 Email: Shashi.Malhotra@fda.hhs.gov SUBJECT: NOT-FD-18-16: Development
More informationRegulatory Challenges of Global Drug Development in Oncology. Jurij Petrin, M.D. Princeton, NJ
Regulatory Challenges of Global Drug Development in Oncology Jurij Petrin, M.D. Princeton, NJ Topics General global R&D issues Regulatory issues with global oncology drug development US FDA initiatives
More informationSpeakers Title & Biography
Speakers Title & Biography Dr. Janice M. Soreth Deputy Director, FDA Europe Office/CDER, Liaison to EMA Dr. Soreth 20-year agency veteran with unparalleled experience, including serving as CDER's director
More informationCONTRACT RESEARCH SERVICES
1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954) 321-9778 info@receptopharm.com www.receptopharm.com ReceptoPharm has installed the pathways to develop, produce and supply
More informationCRO partner in Rx/CDx Co-Development
CRO partner in Rx/CDx Co-Development DEDICATED DIALOGUE A sponsored roundtable discussion published in Pharmaceutical Executive Two Covance executives discuss a CRO s role in supporting Companion Diagnostics
More informationADAPTIVE PATHWAYS WORKSHOP
ADAPTIVE PATHWAYS WORKSHOP Stockholm Friday, November 10, 2017 9:00 13:00 Adaptive Pathways Applications for Scientific Insights in Europe PRESENTED BY: An ICON plc Company Agenda Overview 9:00 9:10 9:10
More informationSo many science careers: find your own niche
So many science careers: find your own niche Kristin Breitschopf sanofi-aventis Deutschland GmbH PhD degree and what next? Scientists have a wide range of career options Huge diversity of career opportunities
More informationQuality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Today, many companies operate
More informationTHE BIOSIMILARS LANDSCAPE: STRATEGIES FOR CLINICAL AND COMMERCIAL SUCCESS
THE BIOSIMILARS LANDSCAPE: STRATEGIES FOR CLINICAL AND COMMERCIAL SUCCESS What all developers need to know Alicia Baker Director, Global Regulatory Affairs Strategy, Covance John Carlsen, MHA Vice President,
More informationStatistical Design Space Development from Design of Experiment to granules Expert of Solids Certification, Seminar 4 April 24 to 25, 2012
Statistical Design Space Development from Design of Experiment to granules Expert of Solids Certification, Seminar 4 April 24 to 25, 2012 Expert of Solids and Master of Solids certificated by Hüttlin GmbH
More informationIndustry Academic Collaboration: A Key to Successful Involvement of Patients Early in Clinical Development
Industry Academic Collaboration: A Key to Successful Involvement of Patients Early in Clinical Development Aernout van Haarst PhD Director, European Corporate Development Feb 2016 Industry Academic Collaboration
More informationThe Value Adding Medical Science Liaison
2-Day Course The Value Adding Medical Science Liaison Understand the role of MSLs within the organisation and how they can optimally add value to both external and internal stakeholders Know how strategic
More informationPost-Baccalaureate Program in Pharmaceutical Science. Accelerate your career
Post-Baccalaureate Program in Pharmaceutical Science Accelerate your career pharmsci.uci.edu pharmsci-grad@uci.edu 949.824.1991 Improve your career options The Post-Baccalaureate Program in Pharmaceutical
More informationCorporate Presentation. October 2017
Corporate Presentation October 2017 Company Overview OPIS is an international CRO providing: - A wide range of clinical and e-clinical services for Pharmaceutical and Biotechnology Industries, Medical
More informationPediatric Drug Development:
Pediatric Drug Development: Where Have We Been and Where Are We Going? Barry Mangum, PharmD, FCP Director Clinical Pharmacology Duke Clinical Research Center Duke University Medical Center Specialty Pediatric
More informationThis is Julius Clinical
This is Julius Clinical WE ARE THE RESEARCH ORGANISATION THAT IS ABLE TO COMBINE THE LATEST SCIENTIFIC INSIGHTS WITH OPERATIONAL EXCELLENCE TO FIND CREDIBLE, CREATIVE, COST-EFFECTIVE SOLUTIONS FOR CLINICAL
More information4.0 HEALTHCARE 4.0. The Data Imperative August 2018 Royal Randwick Turf Club, Sydney ANNUAL CONFERENCE MAJOR SPONSOR
HEALTHCARE 4.0 The Data Imperative 21 23 August 201 Royal Randwick Turf Club, Sydney 4.0 MAJOR SPONSOR Professional Development in Therapeutics 4.0 Join us at this year s ARCS Annual Conference Healthcare
More informationMay 23, :30 PM-5:00 PM - AUDITORIUM A250. May 9, :30 PM -5:00 PM - AUDITORIUM A-950 May 16, :30 PM-5:00 PM - AUDITORIUM A250
DRUG DEVELOPMENT COURSE - FROM MOLECULE TO PRESCRIPTION WEILL CORNELL GRADUATE SCHOOL - TRI-INSTITUTIONAL THERAPEUTICS DISCOVERY INSTITUTE THURSDAYS FROM 3:00PM - 5:00PM AT 1300 YORK AVE, NEW YORK, N.Y.
More informationInternational Transfers of Personal Data at sanofi-aventis R & D
International Transfers of Personal Data at sanofi-aventis R & D Pierre-Yves Lastic, PhD Senior Director, Standards Management & Data Privacy Sanofi-aventis R&D CONFERENCE ON INTERNATIONAL TRANSFERS OF
More informationSTEP 1: INCREASE YOUR ACHIEVEMENTS
KATIE PORTER With more than 15 years of experience in research administration, Katie Porter has co-written two books on research administration: Steer Your Career: A Research Administrator s Manual for
More informationSTARTING STRONGER IN PHASE I THROUGH IIA
PAREXEL CLINICAL RESEARCH SERVICES: EARLY PHASE STARTING STRONGER IN PHASE I THROUGH IIA Adding value from first-in-human through proof-of-concept YOUR JOURNEY. OUR MISSION. Achieve success through early
More informationThe Role of a Clinical Statistician in Drug Development By: Jackie Reisner
The Role of a Clinical Statistician in Drug Development By: Jackie Reisner Types of studies within clinical development Phase I Phase II Phase III Phase IV Phase I First Human Dose (FHD) Young healthy
More informationMODULE 11 Pharmacovigilance March 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES
MODULE 11 Pharmacovigilance 22-23 March 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES Robert VANDER STICHELE M.D., RUG and VUB, Senior Researcher, Health Technology
More informationExploratory IND: a study proposal from Novartis
Exploratory IND: a study proposal from Novartis Rossella Belleli ECD BIOS Novartis 17 Nov 005 Presentation outline What is an exploratory (exp)ind compared to a traditional IND Introduction to traditional
More informationDiploma (Base Course) in Medicines Development
INTRODUCTION The participation in PharmaTrain Project determines the design of the Master in Medicines Development, adapting the syllabus defined in the European project to the current needs of the Spanish
More informationHELPING YOU CREATE SUCCESSFUL EVENTS. THAT S OUR PROMISE TO YOU.
HELPING YOU CREATE SUCCESSFUL EVENTS. THAT S OUR PROMISE TO YOU. At Crowne Plaza Hotels & Resorts, we partner with you to plan and create a uniquely tailored event. Our services and expertise are designed
More informationDrug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research
Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research Drug Development Process by which new chemical entities
More informationStatistical Design Space Development from Design of Experiment to granules Expert of Solids Certification Seminar March 11 to 12, 2014
Statistical Design Space Development from Design of Experiment to granules Expert of Solids Certification Seminar March 11 to 12, 2014 Expert of Solids and Master of Solids certificated by Hüttlin GmbH
More informationKNOW-HOW AND ACCURACY IN CLINICAL RESEARCH
KNOW-HOW AND ACCURACY IN CLINICAL RESEARCH Behind every successful and growing organization lies a strong foundation and a great vision. - Vatché Bartekian President A WINNING TEAM Vatché Bartekian President
More informationKNOW-HOW AND ACCURACY IN CLINICAL RESEARCH
KNOW-HOW AND ACCURACY IN CLINICAL RESEARCH Behind every successful and growing organization lies a strong foundation and a great vision. - Vatché Bartekian President A WINNING TEAM Vatché Bartekian President
More informationSOPs for FDA-Regulated Industry Best Practices to Withstand FDA Expectations
SOPs for FDA-Regulated Industry Best Practices to Withstand FDA Expectations *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! One of the best ways to ensure that an organization
More informationCPTR Mission, Structure & Goals for Innovation
CPTR Mission, Structure & Goals for Innovation Dr. Debra Hanna, PhD Executive Director Critical Path to TB Drug Regimens Event title - DD Month YYYY - Location The Challenge Collaborating for Cures 7 March
More informationHealth Economics for Non-Health-Economists
2-Day Course Health Economics for Non-Health-Economists Understand the terminology, tools, models and argumentation used in health economic evaluation articles Learn to distinguish good from bad ones Know
More informationEFFECTIVE PROCESS VALIDATION NUSAGE PharmEng Pharmaceutical and Biotechnology Training Program Copyright 2014 NUSAGE-PharmEng.
EFFECTIVE PROCESS VALIDATION NUSAGE PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry EFFECTIVE PROCESS VALIDATION Objective
More informationNovartis Business Services HR University Relations. Clinical Sciences and Innovation. Postgraduate Program
Novartis Business Services HR University Relations Clinical Sciences and Innovation Postgraduate Program 2 CLINICAL SCIENCES AND INNOVATION CLINICAL SCIENCES AND INNOVATION 3 The CS&I Postgraduate Program
More information2017 Call for Proposals EDCTP-TDR Clinical Research and Development Fellowships
2017 Call for Proposals EDCTP-TDR Clinical Research and Development Fellowships Call Identifier: TMA2017IF The purpose of this Call for Proposals is to provide funding towards actions that aim to support
More informationTHERAPEUTIC AREAS CARDIOVASCULAR RESEARCH
THERAPEUTIC AREAS CARDIOVASCULAR RESEARCH PPD S CARDIOVASCULAR TEAM: OPTIMIZING TRIALS AND IMPROVING OUTCOMES APPLYING EXPERIENCE, INNOVATION AND EFFICIENCY IN THE FIGHT AGAINST CARDIOVASCULAR DISEASE
More informationBIOSTATISTICAL METHODS
BIOSTATISTICAL METHODS FOR TRANSLATIONAL & CLINICAL RESEARCH Phase 0 Trials: EARLY-PHASE CLINICAL TRIALS Steps to New Drug Discovery Get idea for drug target Develop a bioassay Screen chemical compounds
More informationStrategy & Planning for Commercial Launch Success in Pharma A Cross-functional Approach
2-Day Course Strategy & Planning for Commercial Launch Success in Pharma A Cross-functional Approach Master the critical success factors of a commercial drug launch Learn to design a state-of-the-art multi-channel
More informationBIOSTATISTICAL METHODS FOR TRANSLATIONAL & CLINICAL RESEARCH
BIOSTATISTICAL METHODS FOR TRANSLATIONAL & CLINICAL RESEARCH Phase 0 Trials: EARLY-PHASE CLINICAL TRIALS CLINICAL PHASE Clinical Studies: Class of all scientific approaches to evaluate Disease Prevention,
More informationAT A GLANCE. inventivhealthclinical.com
AT A GLANCE inventivhealthclinical.com 1 Table of Contents OVERVIEW 02 PHASE I-IIA 03 PHASE IIB-III 04 LATE STAGE 05 STRATEGIC RESOURCING 06 BIOANALYTICAL 07 QUALITY ASSURANCE 08 CONSULTING 09 THERAPEUTIC
More informationRecent years have witnessed an expansion in the disciplines encompassing drug
Course overview Recent years have witnessed an expansion in the disciplines encompassing drug discovery outside the pharmaceutical industry. This is most notable with a significant number of Universities
More informationMaster List of Professional Electives Course Title Description Credit Hours. Note: This class only meets for the last 7 class periods of the semester.
Course Number PHTH7044 PHRX7064 PHRX704C PHRX706 PHTH8048 PHRX 904 PHRX 904 Master List of Professional Electives Course Title Description Credit Hours Advanced Cardiac Life Support Emphasis (P only) Advanced
More informationFinding the Balance between Clinical & Commercial Key Roles. Stewart Geary Chief Medical Officer, Senior Vice President, Eisai, Japan
IBC LIFE SCIENCES Part of: 4 TH ANNUAL Grand Copthorne Waterfront Hotel, Finding the Balance between Clinical & Commercial Key Roles Expert Faculty Include: Ajay Tiku Vice President Medical, Asia Pacific,
More informationEuropean Bioanalysis Forum
European Bioanalysis Forum Alternative Approaches for Assessment of Drug Neutralizing Activity of ADA Responses Presenter: Arjen Companjen (on behalf of EBF topic team 19) EIP meeting Lisbon 25 February
More informationBIOPHARMA SOLUTIONS TM Expedite Your Drug Development Program
BIOPHARMA SOLUTIONS TM Expedite Your Drug Program Maximize the Value of Your Asset The journey of drug development can be complex stressful. But it doesn t have to be that way. Join more than 600 biopharmaceutical
More informationThe Pharmaceutical Out-licensing Course
2-Day Course The Pharmaceutical Out-licensing Course For R&D-based Products Be able to decide on the best deal type for products in R&D Know what to include in CDAs, MTAs and term sheets Learn how to prepare
More informationORGANIZATION AND ROLE OF A PHASE I ONCOLOGY UNIT. Dr Philippe CASSIER Centre Léon Bérard, Lyon
ORGANIZATION AND ROLE OF A PHASE I ONCOLOGY UNIT Dr Philippe CASSIER Centre Léon Bérard, Lyon Outline Cancer & Oncology Drug development in oncology Specificity of phase I trials in oncology Study design
More informationToxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development
Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development No. 1 of 10 1. regulates all the drugs products manufactured and sold in the USA. (A) EMEA (B) IND (C) FDA (D) NDA (E) OSHA
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 EFFECTIVE PROCESS VALIDATION Instructor Rick Ng Date and Time 10-11
More informationHow PK and PD analyses drive dataset designs
PharmaSUG 2018 - Paper AA-11 ABSTRACT How PK and PD analyses drive dataset designs David B. Radtke and Brian A. Moser, Eli Lilly and Company Historically, the format of pharmacokinetic analysis datasets
More informationInaugural Fraunhofer Delaware Technology Summit
Inaugural Fraunhofer Delaware Technology Summit Energy and Life Sciences Solu
More information1201 Maryland Avenue SW, Suite 900, Washington, DC ,
1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org May 31, 2012 Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane, Rm. 1061 Rockville, MD
More informationBDA WORKSHOP PROGRAMME. HOW TO MATURE EMERGING TECHNOLOGIES INTO COMPANION DIAGNOSTICS December 2013 BRUSSELS, BELGIUM
BDA WORKSHOP HOW TO MATURE EMERGING TECHNOLOGIES INTO COMPANION DIAGNOSTICS 12-13 December 2013 BRUSSELS, BELGIUM PROGRAMME BIOTHERAPY DEVELOPMENT ASSOCIATION Content The Biotherapy Development Association
More informationMODULE 3 Preclinical safety May 2016 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES
MODULE 3 Preclinical safety 11-12 May 2016 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES René VERLOES M.D., Ph.D., lecturer in preclinical safety of medicines VUB,
More informationGuide for National Scientific and Regulatory Advice
Guide for National Scientific and Regulatory Advice ADV-G0017-3 DATE 18 JULY 2017 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS
More informationDDI May 26 th to 28 th, 2013 Marbach Castle, Germany. Second Announcement
DDI 2013 4 th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions May 26 th to 28 th, 2013 Marbach Castle,
More informationDrug Discovery and Development November 02-03, 2017 Chicago, USA
allied academies BROCHURE International Congress on Drug Discovery and Development November 02-03, 2017 Chicago, USA Theme: Innovations and Advancements in Drug Discovery: Changing the Topography of Pharmaceutical
More informationThe Pharma Brand Planning Course
2-Day Course The Pharma Brand Planning Course Learn how to analyse your brand s market so that you discover all sales levers Know how to determine priority segments and define a value positioning statement
More informationFast Track Drug Development The Clinical (Caleidoscopic) Perspective
20 Years AGAH, Annual Meeting, Hamburg 21.-23. February 2010 Fast Track Drug Development The Clinical (Caleidoscopic) Perspective Fritz R. Bühler, MD ECPM, University of Basel European Innovative Medicine
More informationMay 01 st to 03 rd, 2011 Marbach Castle, Germany. Final Announcement
DDI 2011 2 nd International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions May 01 st to 03 rd, 2011 Marbach Castle,
More informationRUTGERS IJOBS WORKSHOP REGULATORY WRITING JANUARY 30, 2018
1 RUTGERS IJOBS WORKSHOP REGULATORY WRITING JANUARY 30, 2018 Doreen W Lechner, PhD Program Director, MS Clinical Trial Sciences Program Biopharma Educational Initiative Rutgers School of Health Professions
More informationIntroduction to clinical trials
Introduction to clinical trials Definition of a clinical trial A research activity that involves administration of a test treatment to some experimental unit in order to evaluate the treatment. Key words
More informationUncovering the Translational Potential of Protein Degradation
Uncovering the Translational Potential of Protein Degradation November 14 th, 2018 Boston, MA Wednesday, November 14 th 2018 8:00 Registration, Breakfast & Networking 9:00 Chair s Opening Remarks & Setting
More informationtraining programme in pharmaceutical medicine clinical pharmacology
training programme in pharmaceutical medicine clinical pharmacology 04-06 nov 2010 clinical pharmacology 04 06 NOVEMBER 2010 Local: University of Aveiro, Campus Universitário de Santiago Curricular Unit
More informationEXPERT COLLECTION. Explore our leading medical review series
EXPERT COLLECTION Explore our leading medical review series Introducing the EXPERT COLLECTION The Taylor & Francis Expert Collection is the world s largest series of review journals in research, development,
More informationSOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized
More informationPre- ICDRA Exhibition Guide
Pre- ICDRA Exhibition Guide Invitation to Exhibit at PRE- ICDRA 3-4 September 2018 The HPRA is honoured to have been selected by the World Health Organization (WHO) to host delegates from each of the WHO
More informationType of Activity. Universal Activity Number L04-P
Below are the pharmacy designated Universal Activity Numbers (UANs) and type of activity that is applicable for each of the following program offerings Session # Title 104 Impact of Biologics, Vaccines,
More informationA Streamlined Data Capture and Exchange Partnership that Delivers Faster Decisions
A Streamlined Data Capture and Exchange Partnership that Delivers Faster Decisions 2011 SAS Health & Life Sciences Conference Michelle Combs, PhD, VP, Clinical Pharmacology Sciences, Celerion Bernd Doetzkies,
More information2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast
2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As
More informationDose-finding of Small Molecule Oncology Drugs
Dose-finding of Small Molecule Oncology Drugs May 18-19, 2015 Washington Court Hotel, Washington, DC This workshop will provide a forum for discussion of the best practices on dose finding of small molecule
More informationGeneral Information. Keynote Presentation. Hotel Accommodations. Visit our meeting website for registration and more!
Keynote Presentation Kevin Smolar Quality Manager, Sun King Brewing General Information Visit our meeting website for registration and more! https://asclsindiana.eventsmart.com Kevin Smolar has been in
More informationEFFECTIVE CLINICAL TRIALS. NUSAGE PharmEng. Pharmaceutical and Biotechnology Training Program. Copyright 2014 NUSAGE-PharmEng.
EFFECTIVE CLINICAL TRIALS NUSAGE PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry EFFECTIVE CLINICAL TRIALS Objective The intent
More information7th Annual Shanghai Symposium on Clinical and Pharmaceutical Solutions through Analysis
Mechanistic Physiological PhysioPD Models in Drug Development: A Proven Quantitative Systems Pharmacology (QSP) approach Sharan A Pagano SVP, Scientific Alliances at Rosa & Co. LLC 7th Annual Shanghai
More informationPediatric Assessment in Drug Development and Regulatory Approval in Japan
Pediatric Assessment in Drug Development and Regulatory Approval in Japan Mayumi SHIKANO, Ph.D. Associate Director, Center for Product Evaluation Pharmaceuticals and Medical Devices Agency 2016/3/8 1 Disclaimer
More informationMedical Affairs Not a Sunshine Day Analyzing the Impact of the Sunshine Act on Medical Affairs: Challenges for 2014 and Beyond
Medical Affairs Not a Sunshine Day Analyzing the Impact of the Sunshine Act on Medical Affairs: Challenges for 2014 and Beyond Jodi Smith, PhD and Peg Crowley Nowick, PhD, MBA Medical Affairs Not a Sunshine
More information