Clinical Research Services for Dermatology Ophthalmology Allergology Oral Care

Size: px
Start display at page:

Download "Clinical Research Services for Dermatology Ophthalmology Allergology Oral Care"

Transcription

1 Clinical Research Services for Dermatology Ophthalmology Allergology Oral Care About proderm Approach Service Study types Equipment Quality Consulting Site Management Publications

2 2 3 About proderm 2011 Establishment of Sensory Laboratory Incorporation of Oral Care Clinic Trusted Partner What started as a dermatological CRO in 1994 is today a clinical research service provider with an unmatched range of methodology, equipment and highly dedicated scientific experts Start of Hair Care Laboratory 36 proderm was founded in 1994 by Klaus-P. Wilhelm, MD, Professor of Dermatology, a renowned specialist in dermatopharmacology and dermatotoxicology Establishment of Deodorant and Antiperspirant Facilities With the motto 'Dedicated to Skin', the proderm research team has been dedicated since then, body and soul, to conducting clinical dermatological studies This clear focus has been expanded over the years by other core areas such as the indications of ophthalmology, oral hygiene and hair care. Nevertheless, 1997 Opening of Sun Protection Laboratory even after almost 20 years of work, proderm stands primarily for one thing: Continuity! 16 Continuous growth, continuous leadership, continuous independence - last but not least a continuously expanding scientific methods of highest quality Implementation of Pharmaceutical Division 1994 Foundation of proderm # of employees: 4 # of studies p.a.: 40 5 Milestones No. of employees

3 4 5 Services Full Service From early phase consulting until archiving of study data - we are the professional, flexible, and trustworthy partner for your development project. proderm covers all aspects of a clinical trial. Thus, customers have the opportunity to individually define the type and scope of the desired service from our range of services. Cooperation usually starts with the development of an optimal study design and continues with obtaining the regulatory approval. After suitable patients or volunteers are recruited and the study is conducted in our clinical unit, the project is finalized by Data Management, Statistics and Medical Writing. Regardless of the type and scope of the project, with a total of 95 employees, we always assure that there is a substitute for all functions. With that we can react with high flexibility to the needs of our customers, even in times of high workload. a Consultancy a Regulatory Approval a Patient Recruitment a Project Management a Data Management a Statistics a Report Writing a Archiving

4 6 7 Approach Providing Professional Solutions Dedicated experts, innovative equipment and experience are the success ingredients of the professional solutions we offer for both individual and standard study objectives. We combine our passion for clinical research with our approach towards quality. For this reason, proderm stands not only for dedication, but also for professionalism, scientific methods and innovation. a Professional a Scientific a Innovative This is the foundation of our daily work, in which the needs of our customers take center stage. This is also our impetus for continuously striving for improvement. There are no differences made. Whether a top ten global player, a medium-sized enterprise or a startup, whether a standard test or an individual study design our principles are applied to all projects at all times.

5 8 9 Study types Safety & Tolerance Efficacy & Claim Support proderm conducts clinical phase I/IIa trials for pharmaceuticals, medical devices, cosmetics, food supplements and consumer products. In most cases, it is a matter of proving the tolerability or efficacy of topically applied products. Systemically acting products are also investigated as long as the primary target criteria are the effects on the skin or mucous membrane. With the proderm Pharma and proderm Cosmetics departments, proderm is embracing the fact that the regulatory environment and thus the conditions for a clinical trial vary greatly depending on the product to be tested. Under the direction of Dr. Reinhold Gahlmann, proderm Pharma investigates in predominantly monocentric trials: the local tolerability of topical medicines the bioequivalence of corticosteroids the efficacy of drugs or topical medical devices in proof-of-concept studies. At the same time, proderm Pharma has a network of qualified investigators in clinics and practices for multi-center studies. a Pharmaceuticals a Medical Devices a Cosmetics a Food Supplements a Consumer goods a Skin Care a Oral Care a Hair Care a Eye Care a Sun Protection a Intimate Hygiene Stefan Bielfeldt and his team in the proderm Cosmetics Division focus on the tolerability and proof of efficacy of cosmetics, food supplements and consumer products.

6 10 11 Equipment Experienced, Innovative, One of a Kind The multitude of innovative technologies (i.e. Raman Spectroscopy) and the extensive knowledge of our researchers to apply these techniques make us a one of a kind CRO. Our technical equipment goes far beyond known standards and is unique in the global CRO landscape. Thus, we are, for example, one of the few institutes that can offer the non-invasive technologies of confocal microscopy and Raman spectroscopy in combination. At the same time, we set benchmarks by our own developments. With our USR-CliP (Unit for Standardized and Reproducible Clinical Photography), we can, for example, achieve a high level of reproducibility and color fidelity in clinical photography. Our MacIS (Macroscopic Imaging System), on the other hand, allows unparalleled standardized macro photography. a 3D Scanners for Profilometry a In-vivo Confocal Microscopy a In-vivo Confocal Raman Spectroscopy a Clinical Photography a IR Thermography a Laser Perfusion Imaging a Radiometers a Videomicroscopy a UV Radiation Devices a Force Meters In our tests, we combine the various technologies in a validated environment and can thus present our sponsors with undreamt of solutions.

7 12 13 Quality Comprehensive Quality Management and ISO Certification Our service is of high quality, and we attach great importance to this. It is therefore not surprising that our quality management system goes far beyond the standards and we are the first German dermatological CRO to have received ISO certification. Compliance with ethical standards, current legal requirements and standards, the assurance of credible and valid data, reliable compliance with target dates and, last but not least, the continuous improvement of our products and services are aspects that we emphasize in our quality management system. Our system of standard operating procedures, quality control, qualification and training has proven itself in audits by customers and authorities, and is certified according to ISO a Quality Control a System Audits a Study Audits a Validation a Qualification a Training

8 14 15 Consulting 100 Years of Clinical Research Experience Make use of our problem-solving capabilities and go the right path from the very beginning. You are not going the way of the standards but are blazing a new trail with your product. Your innovative formulations require a pioneering spirit and scientific excellence of the clinical implementation. Your product offers properties that cannot be proven by conventional methods. Institute founder Prof. Dr. Klaus-P. Wilhelm and the senior consultant team with Dr. Reinhold Gahlmann, Stefan Bielfeldt and Dr. Dorothea Wilhelm will steer your project in the desired direction from the very start with their over 100 years of combined experience. In addition, you will be taken care of by experts who, with experience from more than 6,000 studies and over 30,000 examined products, will hold the steering wheel firmly in their hand and accompany you on your way with advice and action to solve even the greatest challenges. a Comprehensive publications a Comprehensive academic network a Close contacts to responsible authorities a Active in national and international working scientific groups and societies Because of our extensive inventory of technical equipment, you will benefit from a maximum of flexibility and methods developed explicitly for your project..

9 16 17 Site Management Publications Beyond Phase I: Hospitals and Dermatologic Offices Master the multicenter challenge with the proderm network of qualified investigators. The distinctive idea of service, the passion for clinical research, the demands for quality and professionalism - our test centers have been qualified in multiple ways in order to be included in our network of clinical testing facilities. As the primary responsible CRO, we will gladly support your project with this established network through and beyond phase I in the multicenter phases of development. Of course, the multicenter study can also be the start of our collaboration. Whether starting or continuing a successful cooperation, we assume the following tasks: Creating the test protocol Obtaining the regulatory approvals and ethics opinions Organization of the investigator's meeting Training & evaluator calibration Site initiation Monitoring Data management Statistics Report writing Extract of recent Publications Bielfeldt S, Röck C and Wilhelm KP, Chances and limits of an improved method to assess water resistance of cosmetic sunscreen products in vitro on polymethylmethacrylate plates. Int J Cosmet Sci: 1-5, Bielfeldt S, Henss R, Koop U, Degwert J, Heinrich U, Jassoy C, Meyer J, Tronnier H, Jentzsch A and Blume G, Internet-based lay person rating of facial photographs to assess effects of a cleansing product and a decent cosmetic foundation on the attractiveness of female faces. Int J Cosmet Sci: 1-5,2012. Wilhelm D, Himmelmann A, Axmann E-M, Wilhelm K-P, Clinical efficacy of a new tooth and tongue gel applied with a tongue cleaner in reducing oral halitosis, Quintessence Int, 43: , 2012 Daehnhardt-Pfeiffer S, Surber C, Wilhelm K-P, Daehnhardt D, Springmann G, Boettcher M, Foelster-Holst R, Noninvasive stratum corneum sampling and electron microscopical examination of skin barrier integrity: pilot study with a topical glycerin formulation for atopic dermatitis, Skin Pharmacol Physiol 25, 155, Steiling W, Buttgereit P, Hall B, O'Keeffe L, Safford B, Tozer S and Coroama M, Skin exposure to deodorants/antiperspirants in aerosol form. Food Chem Toxicol, 50: , Bielfeldt S, Böhling A and Wilhelm K-P, Bioengineering methods to assess aging parameters in the depth of the skin. SOFW Journal, 137: 2-9, 2011.

10 proderm Institute for Applied Dermatological Research GmbH Kiebitzweg Schenefeld/Hamburg Tel: Fax:

Cosmetic Oils in comparison: penetration and occlusion of paraffin oil and vegetable oils

Cosmetic Oils in comparison: penetration and occlusion of paraffin oil and vegetable oils Cosmetic Oils in comparison: penetration and occlusion of paraffin oil and vegetable oils By Dr. Matthias Hauser, J&J Consumer Healthcare Germany, 41470 Neuss Introduction The skin represents an effective

More information

Sheffield Kidney Institute. Planning a Clinical Trial

Sheffield Kidney Institute. Planning a Clinical Trial Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase

More information

INTENSIVE COURSE IN DERMATO-COSMETIC SCIENCES

INTENSIVE COURSE IN DERMATO-COSMETIC SCIENCES INTENSIVE COURSE IN DERMATO-COSMETIC SCIENCES BRUSSELS 8-12 Sept 2008 Key questions to be tackled by the course How to realise daily skin care and how to deal with the delicate napkin zone? How important

More information

Job Profile Clinical Research Associate III (CRA)

Job 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 information

medical vision group

medical vision group medical vision group «We value our customers and partners as people with practical, professional and emotional expectations. To fulfill them, is our mission.» medicalvision I N N O V A T I V E S O L U

More information

A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT

A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT Accelovance 2275 Research Boulevard, Suite 700 Rockville, MD 20850, United States Phone: +1.240.238.4900 Fax: +1.240.238.4901 Internet: www.accelovance.com email: gsmith@accelovance.com Contact Person:

More information

A Second Opinion for Subjective Endpoints: The Case for an Endpoint Assessment Committee

A Second Opinion for Subjective Endpoints: The Case for an Endpoint Assessment Committee A Second Opinion for Subjective Endpoints: The Case for an Endpoint Assessment Committee Introduction to EAC The FDA s recent guidance on imaging standards and increased frequency of requests for a Blinded

More information

Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry

Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry By http://www.clinicalresearchassociate cra.com/studyguide/ A clinical research associate (CRA) is a

More information

Regulatory requirements for Australia: Medicines, Cosmetics, Household Cleaning and Food Products RFA 2014

Regulatory requirements for Australia: Medicines, Cosmetics, Household Cleaning and Food Products RFA 2014 Regulatory requirements for Australia: Medicines, Cosmetics, Household Cleaning and Food Products Overview Regulation of medicines in Australia Regulation of cosmetic and household products in Australia

More information

A clinical research organization

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

More information

Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products

Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

The 505(b)(2) Drug Development Pathway:

The 505(b)(2) Drug Development Pathway: The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway By Mukesh Kumar, PhD, RAC and Hemant Jethwani, MS The 505(b)(2) regulation offers a less expensive

More information

Inspections, Compliance, Enforcement, and Criminal Investigations

Inspections, Compliance, Enforcement, and Criminal Investigations Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Jabones Pardo S.A.

More information

Advancing research: a physician s guide to clinical trials

Advancing research: a physician s guide to clinical trials Advancing research: a physician s guide to clinical trials Recruiting and retaining trial participants is one of the greatest obstacles to developing the next generation of Alzheimer s treatments Alzheimer

More information

Clinical Data for Medical Devices

Clinical Data for Medical Devices White Paper Clinical Data for Medical Devices Preparing for increased requirements in the EU Table of Contents 1. Regulation of medical devices in the EU: on the cusp of change... 3 2. Traditional differences

More information

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,

More information

The FDA recently announced a significant

The FDA recently announced a significant This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction

More information

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process

More information

Clinical Trials: Improving the Care of People Living With Cancer

Clinical Trials: Improving the Care of People Living With Cancer CLINICAL TRIALS Clinical Trials: Improving the Care of People Living With Cancer Presented by Mary McCabe, RN, MA Memorial Sloan-Kettering Cancer Center Carolyn Messner, DSW CancerCare Learn about: Stages

More information

Annex 7 Guidelines for the preparation of a contract research organization master file

Annex 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 information

Medical personnel are growing more aware of the extent of an esthetician s

Medical personnel are growing more aware of the extent of an esthetician s Chapter 1 Defining Roles Medical personnel are growing more aware of the extent of an esthetician s training and realizing the potential value in bringing an esthetician into the medical environment. Working

More information

Technology and Expertise Add Operational Value to Medical Device Trials

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

More information

International Aloe Science Council Certified Facility and Products

International Aloe Science Council Certified Facility and Products Aloe vera L. Simply, the most extensively tested Aloe vera available Aloecorp, Inc International Aloe Science Council Certified Facility and Products Qmatrix The GRAS Ingredient A Highly Purified Fraction

More information

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 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 information

BioWales 2015 Pharmaceutical Supply Chain Showcase. 04 March 2015

BioWales 2015 Pharmaceutical Supply Chain Showcase. 04 March 2015 BioWales 2015 Pharmaceutical Supply Chain Showcase 04 March 2015 SIMBEC RESEARCH 40 YEARS EXPERIENCE IN EARLY STAGE CLINICAL DRUG DEVELOPMENT BACKGROUND Over 1,200 clinical studies safely and successfully

More information

CHPA ASSOCIATE MEMBER Rx-to-OTC Switch Resource List

CHPA ASSOCIATE MEMBER Rx-to-OTC Switch Resource List CHPA ASSOCIATE MEMBER Rx-to-OTC Switch Resource List 3D Communications Cynthia DiBiasi Partner cdibiasi@3dcommunications.us 301-320-9331 3D Communications is a strategic communications and training firm

More information

Overview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience

Overview. 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 information

General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff

General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff General Wellness: Policy for Low Risk Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document

More information

INVITATION LETTER ASSIGNMENT TITLE: INDIVIDUAL CONSULTANCY SERVICES RELATED TO THE TRAINING ON ADVANCED GCP TRAINING FOR RBC/MRC.

INVITATION LETTER ASSIGNMENT TITLE: INDIVIDUAL CONSULTANCY SERVICES RELATED TO THE TRAINING ON ADVANCED GCP TRAINING FOR RBC/MRC. INVITATION LETTER COUNTRY: RWANDA SOURCE OF FUNDS: ORDINARY BUDGET ASSIGNMENT TITLE: INDIVIDUAL CONSULTANCY SERVICES RELATED TO THE TRAINING ON ADVANCED GCP TRAINING FOR RBC/MRC. REFERENCE NUMBER: 034/CS/ICS/2014-2015/RBC-MRC

More information

Novartis Investigator Initiated Trials (IITs) Guidelines

Novartis Investigator Initiated Trials (IITs) Guidelines Novartis Investigator Initiated Trials (IITs) Guidelines Introduction and background As part of our commitment to delivering innovative therapies to patients worldwide, Novartis believes in the need to

More information

QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY OCCUPATION: RESEARCH AND DEVELOPMENT REFERENCE ID: LFS/Q0503

QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY OCCUPATION: RESEARCH AND DEVELOPMENT REFERENCE ID: LFS/Q0503 h QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY Contents OS describe what individuals need to do, know and understand in order to carry out a particular job role or function OS

More information

Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services

Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services Providing a wide range of clinical research services Abt Associates Clinical Trials (AACT) is dedicated to providing

More information

Even we will get to use your product someday. Enough reason for us to deliver.

Even we will get to use your product someday. Enough reason for us to deliver. Even we will get to use your product someday. Enough reason for us to deliver. ClinInvent: Putting our heart and soul behind the research. At ClinInvent, when we talk about clinical research it s not just

More information

Responsibilities of Test Facility Management & Sponsor Rik Hendriks Werner Coussement

Responsibilities of Test Facility Management & Sponsor Rik Hendriks Werner Coussement Responsibilities of Test Facility Management & Sponsor Rik Hendriks Werner Coussement J&J R&DQA, Beerse, Belgium rhendrik@prdbe.jnj.com J&J GPCD, Beerse, Belgium wcoussem@prdbe.jnj.com Responsibilities

More information

Applications of nanotechnology: Cosmetics

Applications of nanotechnology: Cosmetics Applications of nanotechnology: Cosmetics Course on Health Effects of Engineered Nanomaterials Finnish Institute of Occupational Health, 23 April 2013 Sari Karjomaa Finnish Cosmetic, Toiletry and Detergent

More information

Clinical database/ecrf validation: effective processes and procedures

Clinical database/ecrf validation: effective processes and procedures TITOLO SLIDE Testo Slide Testo Slide Testo Slide Clinical database/ecrf validation: effective processes and procedures IV BIAS ANNUAL CONGRESS Padova September, 26 th 2012 PQE WORKSHOP: What's new in Computerized

More information

MicroSilver BG TM. The innovative agent for beautiful, healthy skin.

MicroSilver BG TM. The innovative agent for beautiful, healthy skin. The innovative agent for beautiful, healthy skin. Inhalt Why MicroSilver BG TM? 3 What is MicroSilver BG TM? 3 How does MicroSilver BG TM work? 3 Products and usage 4 MicroSilver BG TM still used today

More information

White paper: FDA Guidance for Industry Update Process Validation

White paper: FDA Guidance for Industry Update Process Validation White paper: FDA Guidance for Industry Update Process Validation In January 2011, the FDA released the final version of its long-awaited update to its Process Validation Guidance for Industry. Since then,

More information

Supplement to the Guidance for Electronic Data Capture in Clinical Trials

Supplement to the Guidance for Electronic Data Capture in Clinical Trials Supplement to the Guidance for Electronic Data Capture in Clinical Trials January 10, 2012 Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Note: The original language of this

More information

Guidance for Industry Computerized Systems Used in Clinical Investigations

Guidance for Industry Computerized Systems Used in Clinical Investigations Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) May 2007 Guidance

More information

We set things in motion and keep them moving. Metronomia Clinical Research Services

We set things in motion and keep them moving. Metronomia Clinical Research Services We set things in motion and keep them moving Metronomia Clinical Research Services Our customers love the fact that we keep up with their individual tempos. Dorothea Wessiepe, Director Biostatistics Metronomia:

More information

TEMPLATE DATA MANAGEMENT PLAN

TEMPLATE DATA MANAGEMENT PLAN TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager

More information

clinical Trials - A Need for Organisational Change

clinical Trials - A Need for Organisational Change Contents 42 Research in India: Tomorrow and Beyond India has been a popular destination for clinical trials and, as there is an increasing acceptance of Indian data, Viraj Rajadhyaksha stresses that there

More information

SIB70110 Graduate Certificate in Intense Pulsed Light and Laser Hair Reduction

SIB70110 Graduate Certificate in Intense Pulsed Light and Laser Hair Reduction SIB70110 Graduate Certificate in Intense Pulsed Light and Laser Hair Reduction Release: 2 SIB70110 Vocational Graduate Certificate in Intense Pulsed Light and Laser Hair Reduction Modification History

More information

Guidance for Industry

Guidance for Industry Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer U.S. Department of Health and Human Services Food and Drug Administration Center

More information

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure

More information

PAGE 1 PROJECT MANAGEMENT COMPETENCE CENTER SETTING MILESTONES PMCC CONSULTING

PAGE 1 PROJECT MANAGEMENT COMPETENCE CENTER SETTING MILESTONES PMCC CONSULTING COMPETENCE CENTER PAGE 1 SETTING MILESTONES PMCC CONSULTING PAGE 2 COMPETENCE CENTER SETTING MILESTONES PMCC CONSULTING PAGE 4 PMCC CONSULTING PMCC CONSULTING The ability to professionally manage strategies,

More information

OVERVIEW OF CURRENT STATUS OF STEM CELL TRANSPLANTATION IN VIETNAM

OVERVIEW OF CURRENT STATUS OF STEM CELL TRANSPLANTATION IN VIETNAM Ministry Of Health National Institute of Hematology and Blood Transfusion OVERVIEW OF CURRENT STATUS OF STEM CELL TRANSPLANTATION IN VIETNAM Prof. Nguyen Anh Tri MD., PhD., Director of NIHBT (Vietnam)

More information

Image Archiving for Digital Pathology

Image Archiving for Digital Pathology Pathology Informatics 2011 Image Archiving for Digital Pathology Which Way to Turn? Glenn Taylor, MD, FRCPC, FACP Head, Division of Pathology, Hospital for Sick Children Associate Professor, University

More information

Revised checklist for BA/BE NOC effective from 01 st February 2014 (Draft for comments before 25 Jan 14)

Revised checklist for BA/BE NOC effective from 01 st February 2014 (Draft for comments before 25 Jan 14) Revised checklist for BA/BE NOC effective from 01 st February 2014 (Draft for comments before 25 Jan 14) Documents to be submitted for grant of permission to conduct BA/BE studies in Human Subjects/Patients

More information

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor The Concept of Quality in Clinical Research Dorota Śwituła Senior Clinical Quality Assurance Advisor 1 Agenda What is quality? How we define quality in clinical research? The standard components of a Quality

More information

Cosmetic products safety regulations

Cosmetic products safety regulations Cosmetic products safety regulations Trading Standards Information www.southwark.gov.uk 1. Introduction Cosmetic products are subject to EU wide safety regulations. They must not be liable to cause damage

More information

BEST PRACTICE FOR MAXIMUM TABLET QUALITY, AVOIDING THE FDA WARNING LETTER 483.

BEST PRACTICE FOR MAXIMUM TABLET QUALITY, AVOIDING THE FDA WARNING LETTER 483. White Paper ORAL SOLID DOSAGE: THE TABLET BEST PRACTICE FOR MAXIMUM TABLET QUALITY, AVOIDING THE FDA WARNING LETTER 483. During the period 2008 through 2011, the FDA drew up 42 warning letters recalling

More information

Nutraceutical Medical Research, LLC. By: Latesha Richards, Marketing Coordinator

Nutraceutical Medical Research, LLC. By: Latesha Richards, Marketing Coordinator The Value of Conducting Post-Marketing Clinical Research On Marketing Strategy Development Nutraceutical Medical Research, LLC By: Latesha Richards, Marketing Coordinator Those of us who are marketing

More information

Patient Handbook on Stem Cell Therapies

Patient Handbook on Stem Cell Therapies Patient Handbook on Stem Cell Therapies Appendix I of the Guidelines for the Clinical Translation of Stem Cells www.isscr.org 2008, International Society for Stem Cell Research 2 Introduction We have all

More information

History and Principles of Good Clinical Practice

History 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 information

CRITERIA FOR ACCREDITING APPLIED SCIENCE PROGRAMS

CRITERIA FOR ACCREDITING APPLIED SCIENCE PROGRAMS CRITERIA FOR ACCREDITING APPLIED SCIENCE PROGRAMS Effective for Reviews During the 2012-2013 Accreditation Cycle Incorporates all changes approved by the ABET Board of Directors as of October 29, 2011

More information

Annex 7 Guidelines on pre-approval inspections

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

More information

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 The innovative pharmaceutical industry 2 is committed to the transparency

More information

Mayo Alliance for Clinical Trials

Mayo Alliance for Clinical Trials Mayo Alliance for Clinical Trials A Division within Mayo Clinical Trial Services PROFESSIONAL CLINICAL TRIALS SERVICES ADVANCING PATIENT CARE THROUGH SCIENTIFIC DISCOVERY It is a great thing to make scientific

More information

Advanced Performance and Responsibility Guidelines for the Nuclear Medicine Technologist. SUMMARY. Introduction 2

Advanced Performance and Responsibility Guidelines for the Nuclear Medicine Technologist. SUMMARY. Introduction 2 Advanced Performance and Responsibility Guidelines for the Nuclear Medicine Technologist. SUMMARY Page Introduction 2 Chapter 1 : Management Topics 4 Chapter 2 : Information Management 6 Chapter 3 : Management

More information

Statistical Operations: The Other Half of Good Statistical Practice

Statistical Operations: The Other Half of Good Statistical Practice Integrating science, technology and experienced implementation Statistical Operations: The Other Half of Good Statistical Practice Alan Hopkins, Ph.D. Theravance, Inc. Presented at FDA/Industry Statistics

More information

Hygiene License, Record-keeping Certificate & CIQ Labels for Imported Cosmetics in China

Hygiene License, Record-keeping Certificate & CIQ Labels for Imported Cosmetics in China Hygiene License, Record-keeping Certificate & CIQ Labels for Imported Cosmetics in China China is the cosmetics market with a huge growth potential in the future. According to forecasts, the Chinese cosmetics

More information

STAR Deutschland GmbH

STAR Deutschland GmbH STAR Deutschland GmbH Our quality management system certified to ISO 9001:2008 STAR Group Your single-source partner for corporate product communication Our quality management manual... The quality management

More information

CRITERIA FOR ACCREDITING APPLIED SCIENCE PROGRAMS

CRITERIA FOR ACCREDITING APPLIED SCIENCE PROGRAMS CRITERIA FOR ACCREDITING APPLIED SCIENCE PROGRAMS Effective for Reviews During the 2015-2016 Accreditation Cycle Incorporates all changes approved by the ABET Board of Directors as of November 1, 2014

More information

EHR (Electronic Health Record) based EDC for Clinical Trials and Quality Outcome in Eye Care. The new World of Clinical Research in Eye Care

EHR (Electronic Health Record) based EDC for Clinical Trials and Quality Outcome in Eye Care. The new World of Clinical Research in Eye Care EHR (Electronic Health Record) based EDC for Clinical Trials and Quality Outcome in Eye Care The new World of Clinical Research in Eye Care 1 The new World of Clinical Research in Eye Care The electronic

More information

YOuR SuppLIER for InnOvaTIvE and ERp-IndEpEndEnT finance SOLuTIOnS. perfection In detail.

YOuR SuppLIER for InnOvaTIvE and ERp-IndEpEndEnT finance SOLuTIOnS. perfection In detail. 13 YOuR SuppLIER for InnOvaTIvE and ERp-IndEpEndEnT finance SOLuTIOnS perfection In detail. 2 3 About Cogon Your Supplier for innovative and ERp-independent Finance solutions The name cogon, derived from

More information

Accelerating Clinical Trials Through Shared Access to Patient Records

Accelerating Clinical Trials Through Shared Access to Patient Records INTERSYSTEMS WHITE PAPER Accelerating Clinical Trials Through Shared Access to Patient Records Improved Access to Clinical Data Across Hospitals and Systems Helps Pharmaceutical Companies Reduce Delays

More information

Temple 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. 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 information

Infoset builds software and services to advantage business operations and improve patient s life

Infoset builds software and services to advantage business operations and improve patient s life Infoset builds software and services to advantage business operations and improve patient s life Clinical Data Management ecrf & EDC Patient Support Programs Medication Adherence Mobile e-health Big Data

More information

The Clinical Trials Process an educated patient s guide

The Clinical Trials Process an educated patient s guide The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-

More information

A Guide to Clinical Trials

A Guide to Clinical Trials A Guide to Clinical Trials For young people with cancer and their parents Children s Cancer and Leukaemia Group www.cclg.org.uk Original booklet produced in conjunction with the CCLG Patient Advocacy Committee.

More information

Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services

Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services LABORATORY TESTING SERVICES YOUR PARTNER IN LABORATORY MEDICINE The key note of progress in the 20th century is

More information

INDUSTRY OVERVIEW OVERVIEW OF HONG KONG ECONOMY. GDP, disposable income and consumption expenditure

INDUSTRY OVERVIEW OVERVIEW OF HONG KONG ECONOMY. GDP, disposable income and consumption expenditure The information and statistics set out in this section are derived from official or government publications and industry sources as well as the Ipsos Report. The information extracted from the Ipsos Report

More information

Content Sheet 12-1: Overview of Personnel Management

Content Sheet 12-1: Overview of Personnel Management Content Sheet 12-1: Overview of Personnel Management Role in quality management system Personnel are the most important laboratory resource. Critical to the implementation of the quality management system

More information

Clinical Trial Logistics

Clinical Trial Logistics Company Brochure Clinical Trial Logistics contents 1. 2. 3. 4. 5. 6. About us Values Facility Quality Management System Services Why PCS Clinical Trial Logistics about us MEET US PHARMA COMPLEX SOLUTIONS

More information

SCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL DRUG TRIALS

SCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL DRUG TRIALS UDC 615:519.076 Dobrova V. Ye., Zupanets K. O., Ratushna K. L. National University of Pharmacy SCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL

More information

Competency Statements for Dental Public Health*

Competency Statements for Dental Public Health* Competency Statements for Dental Public Health* Preamble Competency statements for dental public health, and the performance indicators by which they can be measured, were developed at a workshop in San

More information

THE ACTIVITIES AND FUTURE DEVELOPMENT OF GCP INSPECTIONS IN TANZANIA

THE ACTIVITIES AND FUTURE DEVELOPMENT OF GCP INSPECTIONS IN TANZANIA THE ACTIVITIES AND FUTURE DEVELOPMENT OF GCP INSPECTIONS IN TANZANIA Godwin D. Ndossi, PhD Chairman Tanzania National Health Research Forum Formerly, Managing Director Tanzania Food and Nutrition Centre

More information

WHITE PAPER: ADAPTIVE CLINICAL TRIALS

WHITE PAPER: ADAPTIVE CLINICAL TRIALS WHITE PAPER: ADAPTIVE CLINICAL TRIALS P. Ranganath Nayak, Chief Executive Officer, Cytel Inc. James A. Bolognese, Senior Director, Cytel Consulting The Adaptive Concept The clinical development of drugs

More information

PEOPLE > SCIENCE > SOLUTIONS

PEOPLE > SCIENCE > SOLUTIONS PEOPLE > SCIENCE > SOLUTIONS Our difference Our foundation Our focus ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY (Functional testing) BIOCOMPATIBILITY (in vivo & in vitro toxicology) CLINICAL

More information

Full-time or part-time upto 1.0 FTE, 4 year fix term Principal Investigator Department of Cardiology Westmead Hospital

Full-time or part-time upto 1.0 FTE, 4 year fix term Principal Investigator Department of Cardiology Westmead Hospital Position Description POSITION TITLE Project Manager TYPE OF EMPLOYMENT Full-time or part-time upto 1.0 FTE, 4 year fix term REPORTING TO a) Principal Investigator DIVISION Department of Cardiology COMPANY

More information

TALENT MANAGEMENT SOLUTIONS TO THE CRA SHORTAGE: Investing in a Global Talent Pool

TALENT MANAGEMENT SOLUTIONS TO THE CRA SHORTAGE: Investing in a Global Talent Pool TALENT MANAGEMENT SOLUTIONS TO THE CRA SHORTAGE: Investing in a Global Talent Pool inventivhealth.com/clinical Over the past few years, the field of clinical research has been hampered by a shortage of

More information

SARS Expert Committee. Training on Public Health

SARS Expert Committee. Training on Public Health For information SARS Expert Committee Training on Public Health Purpose This paper provides an overview on training for doctors, nurses and laboratory staff in the Department of Health (DH) particularly

More information

Structure of State Regulatory Authorities REGISTRATION CERTIFICATE ISSUING AUTHORITY ROSZDRAVNADZOR

Structure of State Regulatory Authorities REGISTRATION CERTIFICATE ISSUING AUTHORITY ROSZDRAVNADZOR PRESENTATION REGISTRATION OF PHARMACEUTICAL PRODUCTS IN RUSSIA Alyona Chorich, Regulatory Affairs Manager PharmaReg, Moscow 1. Registration in Russia conception. Pharmaceutical products / food supplements

More information

Agile Master Data Management TM : Data Governance in Action. A whitepaper by First San Francisco Partners

Agile Master Data Management TM : Data Governance in Action. A whitepaper by First San Francisco Partners Agile Master Data Management TM : Data Governance in Action A whitepaper by First San Francisco Partners First San Francisco Partners Whitepaper Executive Summary What do data management, master data management,

More information

298.015) UC 6:30 8:20 PM

298.015) UC 6:30 8:20 PM Course Description: This course is an in depth review of the history, authorizing statute and regulatory authority of US FDA and the influence and impact of FDA on science and health policy. Drug development,

More information

FDA Guidance for Industry Update - Process Validation

FDA Guidance for Industry Update - Process Validation FDA Guidance Update: Process Validation: General Principles and Practices White Paper FDA Guidance for Industry Update - Process Validation The changing face of Validation; are IQ, OQ and PQ really dead

More information

Clinical trials in haemophilia

Clinical trials in haemophilia Clinical trials in haemophilia Dr. Paul Giangrande Oxford Haemophilia and Thrombosis Centre & Nuffield Department of Clinical Medicine University of Oxford paul.giangrande@ndm.ox.ac.uk Why do clinical

More information

Hanover Center for Optical Technologies - HOT

Hanover Center for Optical Technologies - HOT Hanover Center for Optical Technologies - HOT apl. Prof. Dr. Bernhard Roth Bernhard.Roth@hot.uni-hannover.de www.hot.uni-hannover.de Hannover, November 18 th, 2014 Hannoversches Zentrum für Optische Technologien

More information

11. Extension Potential Financial Benefits

11. Extension Potential Financial Benefits 11. Extension Potential Financial Benefits Estimating the financial value of using electronic health records (EHR) for clinical research is fraught with difficulties for a number of reasons, some of which

More information

EU ECOLABEL FOR ABSORBENT HYGIENE PRODUCTS

EU ECOLABEL FOR ABSORBENT HYGIENE PRODUCTS EU ECOLABEL FOR ABSORBENT HYGIENE PRODUCTS BEUC and EEB position on proposal to be voted on 14 th of March 2014 Contact: Blanca Morales environment@beuc.eu & blanca.morales@eeb.org Ref.: X/2014/014-05/03/2014

More information

Clinical Trials. In Singapore. Clinical Trials in Asia Pacifi c. Introduction. Healthcare Clusters. www.asiabiotech.com

Clinical Trials. In Singapore. Clinical Trials in Asia Pacifi c. Introduction. Healthcare Clusters. www.asiabiotech.com Clinical Trials In Singapore Dr Say-Beng Tan, Dr Eugene Fidelis Soh, and Dr Han-Chong Toh Introduction Clinical trials are the gold standard for the evaluation of new treatment strategies. New treatments

More information

Presentation of second quarter 2010 results

Presentation of second quarter 2010 results Brilliance in photodynamic technology TM Building a Specialty Pharma company Presentation of second quarter 2010 results 19 August 2010 Kjetil Hestdal, President & CEO Christian Fekete, CFO Photocure is

More information

2Technical Support 3Formulation Development 4Proof of Concept 5 GMP Services 6Advanced Drug Delivery 1EUDRAGIT Products Evonik. Power to create.

2Technical Support 3Formulation Development 4Proof of Concept 5 GMP Services 6Advanced Drug Delivery 1EUDRAGIT Products Evonik. Power to create. GMP Services Solutions for Clinical Sample Manufacturing 1 EUDRAGIT Products 2 Technical Support 3 Formulation Development Proof of Concept 4 5 GMP Services 6 Advanced Drug Delivery Evonik. Power to create.

More information

RBM as Competitive Advantage for Mid-sized CROs

RBM as Competitive Advantage for Mid-sized CROs RBM as Competitive Advantage for Mid-sized CROs Cyntegrity s White Paper Applying RBM analytics to improve patient safety and preventive care Table of Contents Introduction...3 What is Data-driven RBM?...4

More information

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP Document issued on: June 2004 U.S. Department of Health and Human Services Food and Drug Administration

More information

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software

More information

Managing Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey

Managing Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Aim of the session To explore the risks associated with clinical research and understand how

More information

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 Plenary of the National Health Council in its 15 th Special Meeting, held on 5 August 1997, in the exercise of its competencies, as set forth

More information