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  • Sep 2017
    19
    Sep 2017
    21

    Phacilitate

    Meet the future of ATMP commercialisation at Europe’s premier partnering event at Phacilitate’s 3rd Cell & Gene Therapy Europe. Join 400 industry decision-makers and key external stakeholders at the event which defines the strategic roadmap to European success for cell & gene therapy developers, ensuring European patients gain access to the game-changing biotherapeutics of tomorrow.

    Be a part of the only European event that offers extensive coverage of ATMP R&D, manufacturing and regulatory issues and challenges, translating innovation to global success. 

    Berlin, Germany
  • Sep 2017
    19
    Sep 2017
    22

    British Association for the Study of the Liver (BASL)

    BASL2017 Annual Meeting is the leading Liver meeting in the UK bringing together clinicians, nurses, scientists and those interested in liver disease.

    This year, the main meeting opens the Wednesday with a day devoted to cellular senescence. The second day has two streams: first, the interaction between the Liver and the Gut and second, the named lectures. These include the Ralph Wright Lecture (Professor John O’Grady) the British Liver Trust Lecture (Dr. Mary Ramsay), the inaugural Alex Mowat Lecture (Dr. Sue Beath) and the annual Dame Sheila Sherlock Prize Lecture. In the final morning we will follow the model from 2016 with a series of case-based discussions led by recognised experts in the field before a lunchtime departure.

    Other events during the week include:

    British Liver Transplant Group (BLTG) Transplant Meeting: Tuesday 19th – Wednesday 20th September.
    As an affiliate of BASL, the BTLG has built on the role of the UK and Ireland Annual Meeting and will integrate the meetings previously organised by each individual transplant centre to offer a central stage for those operating in or with a strong interest in the field of liver transplantation.

    This year’s meeting will be attended by both eminent UK and international speakers, including Professor Geoff McCaughan University of Sydney, Australia, and Professor Peter Friend who will deliver the distinguished Williams-Calne lecture.

    BASL Nurse Forum Annual Meeting: Thursday 21st September
    The liver nurses hold their Annual Meeting in parallel on the Thursday and this year this has especial importance as it will be celebrating the launch of the newly formed British Liver Nurses Association following a merger of the BLNF & the BASLNF. This day promises to deliver exciting and inspiring sessions for all nurses working within Hepatology, with the programme including a wide range of topics relating to liver disease and its associated issues and challenges.

    For information and registration links at www.baslannualmeeting.org.uk 

    Coventry, United Kingdom
  • Sep 2017
    21
    Sep 2017
    22

    NetZealous DBA as GlobalCompliancePanel

     

    Course "Applied Statistics for Scientists and Engineers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

     

    Overview:

     

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices.

    Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices.

    This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, industry-specific applications are presented for the participants.

     

    Why should you attend:

     

    21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods across the product quality lifecycle.

    According to the Quality System Regulation (QSR) for medical devices, "Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, verifying the acceptability of process capability and product characteristics." Although there are many statistical method that may be applied to satisfy this portion of the QSR, there are some commonly accepted methods that all companies can and should be using to develop acceptance criteria, to ensure accurate and precise measurement systems, to fully characterize manufacturing processes, to monitor and control process results and to select an appropriate number of samples.

    According to both 21 CFR and guidance documents, the need for statistical methods is well established from discovery through product discontinuation. 21 CFR specifies the "the application of suitable statistical procedures" to establish both in-process and final specifications. The guidance documents necessitate the application of statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring the manufacturing process is in control and is capable.

    This course provides instruction statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.

     

    Areas Covered in the Session:

     

    Objectives:

             describe and analyze the distribution of data

             develop summary statistics

             generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

             describe the relationship between and among two or more factors or responses

             understand issues related to sampling and calculate appropriate sample sizes

             use statistical intervals to setting specifications/develop acceptance criteria

             use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

             ensure your process is in (statistical) control and capable

    Who Will Benefit:

     

    This seminar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design:

             Process Scientist/Engineer

             Design Engineer

             Product Development Engineer

             Regulatory/Compliance Professional

             Design Controls Engineer

             Six Sigma Green Belt

             Six Sigma Black Belt

             Continuous Improvement Manager

     

    Agenda:

     

     

    Day 1 Schedule

     

    Lecture 1:

    Basic Statistics

    • sample versus population
    • descriptive statistics
    • describing a distribution of values

    Lecture 2:

    Intervals

    • confidence intervals
    • prediction intervals
    • tolerance intervals

    Lecture 3:

    Hypothesis Testing

    • introducing hypothesis testing
    • performing means tests
    • performing normality tests and making non-normal data normal

    Lecture 4:

    ANOVA

    • defining analysis of variance and other terminology
    • discussing assumptions and interpretation
    • interpreting hypothesis statements for ANOVA
    • performing one-way ANOVA
    • performing two-way ANOVA

     

    Day 2 Schedule

     

    Lecture 1:

    Regression and ANCOVA

    • producing scatterplots and performing correlation
    • performing simple linear regression
    • performing multiple linear regression
    • performing ANCOVA
    • using model diagnostics

    Lecture 2:

    Applied Statistics

    • setting specifications
    • Measurement Systems Analysis (MSA) for assays
    • stability analysis
    • introduction to design of experiments (DOE)
    • process control and capability
    • presenting results

     

    Speaker:

    Richard (Rick) K. Burdick


     

    Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc. for 10 years. He taught at ASU for 29 years at all levels including undergraduate business students, MBAs, Master of Statistics students, and doctoral candidates in both business and engineering. He received numerous teaching awards and taught a variety of courses for adult learners. His research and consulting interests consider several CMC statistical applications including comparability studies, stability data analysis, analytical method validation, quality by design process characterization, and analytical similarity for biosimilar products. He has written over 60 journal articles and three books, including Confidence Intervals for Random and Mixed ANOVA Models with Applications to Gauge R&R Studies, (with C. M. Borror and D. C. Montgomery) and Confidence Intervals on Variance Components, (with F. A. Graybill). Burdick is a Fellow of the American Statistical Association and a member of the American Society for Quality. He has served on the USP Statistics Expert Committee since 2010. He received his Bachelor's Degree in Statistics from the University of Wyoming. He received his Masters and Doctorate degrees in Statistics from Texas A&M University.

     

     

    Location: Baltimore, MD Date:  September 21st & 22nd, 2017 and Time: 9:00 AM to 6:00 PM

    Venue:  The DoubleTree Baltimore-BWI Airport   890 Elkridge Landing Road - Linthicum, MD 21090

     

    Price:

     

    Register now and save $200. (Early Bird)

    Price: $1,295.00 (Seminar Fee for One Delegate)

    Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00 

    Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

     

    Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

     

    At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

    As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

    For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

     

    Contact us today!

     

    NetZealous LLC DBA GlobalCompliancePanel

    john.robinson@globalcompliancepanel.com  

    support@globalcompliancepanel.com 

    Toll free: 1-800-447-9407

    Phone: 1-510-584-9661

     Website: http://www.globalcompliancepanel.com

     

    Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901146SEMINAR?globaleventslist-September-2017-SEO

     

    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

    Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

    Follow us on Twitter: https://twitter.com/GCPanel

     

    Baltimore, MD, United States
  • Sep 2017
    22
    Sep 2017
    24

    LDN Research Trust

    The conference reviews, compares and contrasts the most recent data and treatments for a variety of Auto-Immune and Immuno-modulated Conditions, Pain and Mental Health. This event is LiveStreamed Globally enabling everyone to watch.

     

    Speakers

    Akbar Khan, MD

    Anthony Turel, MD

    Armin , MD, PhD

    Beth, Livengood, NMD

    Brian Udell, MD

    Darrin Ingels, ND

    David Zava, PhD

    Deanna Windham, DO

    Debbie Rice, ND

    Galyn Forster, MS, LPC

    Ginevra Liptan, MD

    Jarred Younger, PhD

    Jill Brook M.A.

    Jill Cottel, MD

    John A. Robinson, NMD

    Kent Holtorf, MD

    Laurie Marzell, ND

    Leonard Weinstock, MD

    Mark Mandel, Pharm D

    Mark Shukhman, MD

    Michael Lugwig, MS

    Nasha Winters, ND

    Paul Anderson, NMD

    Paul Battle, PA-C

    Pradeep Chopra, MD

    Prof. Angus Dalgleish

    Samyadev Datta, MD

    Sarah Zielsdorf, MD

    Stephen Dickson BSC (hons) MRPharmS

     

    Presentations:

    Autism, Bipolar Disorder, Cancer, Case Studies, Celiac, Cost Savings, Crohn's Disease, Type 1 Diabetes, Dissociative Symptoms, Fibromyalgia, Gluten Sensitivity, How to Speak to Doctors, Infertility, LDN and Children, LDN and Pets, Lupus, Lyme Disease and Testing, Mental Health Conditions, Multiple Sclerosis, Nutrition, Pain, Pharmacology, PTSD, POTS, Psoriasis, Restless Leg Syndrome, Sex and LDN Study, SIBO and Irratable Bowel Conditions,Thyroid Conditions, Trial Data, Ulcerative Colitis, Vitamin D and Inflammation - The Case Studies will cover many conditions.

    The 3 Day Conference also has 20 hours of Recorded Presentations.

     

    CE Credits:

    The American Association of Naturopathic Physicians 26 CE Credits

    The Oregon Board of Naturopathic Medicine 27.75 CE Credits

    Portland, United States
  • Sep 2017
    23

    Mayo School of Continuous Professional Development

    This course will provide the latest, state-of-the-art information on the diagnosis and management of common disorders such as esophageal strictures, complications of bariatric surgery, functional GI disorders, colon cancer screening, IBD, fatty liver, Hepatitis B and C, dermatologic manifestation of various GI conditions. In addition, advances in liver transplantation and endoscopic innovations will be presented.    The intended audience includes gastroenterologists, hepatologists, primary care physicians, nurses and advanced healthcare practitioners.

    Course format will offer didactic lectures, panel discussions and interactive Q & A. Active audience participation is strongly encouraged.

    NEW THIS YEAR! Join us for an optional tour of the Proton Beam therapy facility

    Phoenix, United States
  • Sep 2017
    25

    Healthcare Conferences UK

    This national annual summit takes a practical approach to improving practice and outcomes for those living with and beyond cancer, moving from surviving to thriving. Through national updates and practical case studies the conference aims to support you to deliver on the above priorities outlined by NHS England and develop effective cancer survivorship support and services. There will be an extended focus on meeting the unmet needs of people living with and beyond cancer, accelerating the roll-out of stratified follow up pathways and the commissioning of holistic packages of support, and ensuring every person with cancer will have access to relevant elements of the Recovery Package. The conference will also update delegates on the development of the national metric for long term quality of life for cancer patients.   A 20% discount is available by quoting ref: hcuk20ge when booking.

    London, United Kingdom
  • Sep 2017
    25
    Sep 2017
    27

    European Association of Urology Nurses (EAUN)

    By collaborating with EAU and ERUS we are able to provide an educational platform based on best practice with a high standard in urological care. The meeting will offer theoretical in-depth knowledge and optional hands-on training (HOTs) for nurses working in robot-assisted urology surgery.



    Programme:
    The first day will be completely dedicated to the operating room nurse / assistant role in theory and practice and includes state-of-the art lectures on safe positioning, avoiding complications, radical prostatectomy, kidney and bladder cancer, amongst others. Team training, trouble shooting, ethics  and educational video presentations are some of the other important topics that will be discussed with the audience by highly skilled and experienced speakers.

    On day 2 and 3 the nurse delegates will attend the lectures and live surgery sessions of the regular ERUS programme.

    Hands-on training Courses: 
    Also on Day 2 several HOT courses for nurses will be organised. For the full programme of these optional HOTs please visit the separate webpages.
    HOT 1 will be held at the OLV Robotic Training in Surgery Centre (ORSI), and is meant for experienced nurses and RNFAs.
    HOT 2 will be held at the meeting venue and is a joint session communication 
    and simulator training with Mimic, 3D Systems and STAN Institute.
     
    Registration:
    Registration until 25 September 2017
    Early fee deadline: 15 June 2017
     
    More information:
    Scientific Programme: http://erus17.uroweb.org/special-meetings/erus-eaun/
    Registration fees: http://erus17.uroweb.org/special-meetings/erus-eaun-fees/
    Or contact the EAUN by e-mail: eaun@uroweb.org

    Bruges, Belgium
  • Sep 2017
    27
    Sep 2017
    29

    Codex - International Business Leaders Network

    VICTOR HUGO once famously remarked: “No power on earth can resist an idea whose time has come”.

     

    Since the Industrial Revolution, technology has played a unique role in powering growth and transforming economies. Catalysed by the internet, the pace of technological change and scientific progress is accelerating, creating the new industries of the future.

     

    We are inviting the scientists, engineers, entrepreneurs and visionaries who are building the "Industries of the Future", to better understand where new wealth will be created, whilst also examining the impact on the economy and society.

     

    'The World’s Top 50 Innovators from the Industries of the Future' series is to be staged by Codex, International Business Leaders Network, at the BT Auditorium in London on 27th, 28th and 29th September 2017.

     

    Industries of the Future to be examined will include:  

     

    Robotics and Artificial Intelligence

    Big Data

    3D and 4D Printing

    Virtual and Augmented Reality

    Genomics and Digital Health

    Space Technologies

    Cybersecurity

    New Energy Technologies

    Digital Money and Blockchain Technologies

     

     

    Please see link for all confirmed speakers and latest agenda: https://www.codex.com/?p=4947

     

    This will be a global event with distinguished speakers from across the world.

     

    Confirmed speakers will include:

     

    Dr John M Sankovic, Glenn Research Center, Chief Technologist, NASA

    Dr Douglas Terrier, Chief Technologist, NASA

    Amir Khusrowshahi, Chief Technology Officer, Artificial Intelligence, Intel

    Naveen Jain, Executive Chairman, Moon Express

    Patrick Wood, CEO, Surrey Satellite Technology

    Nikita Chen-iun-tai, CEO, Apis Cor

    Caroline Hargrove, Technical Director, McLaren Formula 1

    Dr Graciela Chichilnisky, CEO, Global Thermostat

    Leanne Kemp, CEO, Everledger

    Simon Bransfield-Garth, CEO, Azuri Technologies

    Paul Stein, Chief Technology Officer, Rolls-Royce

    Lawrence Orsini, CEO, LO3 Energy

    Dr Ali Parsa, CEO, Babylon Health

    Gordon Sanghera, CEO, Oxford Nanopore Technologies

    Nicole Eagan, CEO, Darktrace

    Sir Nigel Shadbolt, Big Data Expert, Master of Jesus College, Oxford

    Rich Walker, CEO, Shadow Robot

    Mikko Hypponen, Chief Research Officer, F-Secure

    William McMaster, Head of VR, Visualise

    Richard Nockles, CEO, Surround Vision

    Danny Lopez, COO, Blippar

    Dr Mirko Kovac, Director, Ariel Robotics Lab, Imperial College London

     

     

    Lead Sponsors will include BT 

     

     

    Format

     

    The format will be a series of Codex Talks. A Codex Talk is a concise 15 minute presentation from a speaker with the aim of answering a set question related to their industry or technology area. After 15 minutes, the speaker will be asked to make a bold prediction about their industry.  For the benefits of the live audience, a Q&A will take place overseen by a moderator with all the speakers in the session.

     

    A Codex Talk will give the audience something they can walk away with: valuable insights, actionable information, fresh perspectives, and renewed optimism.

     

    To register online for this event, please visit www.codex.com  The number of attendees will be limited and acceptances are on a first come first served basis. All major credit/debit cards are accepted. Demand for this event is high.  You are advised to register early.

     

    When payment has been successfully made, you will receive a confirmation email from Pay Pal and a written confirmation from Codex.  To join us, please click here to register www.codex.com

     

    Come and join CEOs, tech entrepreneurs, scientists, investors and media, from across the world for one of the most significant conferences on innovation this year, and see live demonstrations of the latest technologies.

    London, United Kingdom
  • Sep 2017
    28
    Sep 2017
    29

    NetZealous DBA as GlobalCompliancePanel

    Course "Design of Experiments (DOE) for Process Development and Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

     

    Overview:

     

    Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.

    The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs, are used to determine critical process parameters. Response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs, are used to model the functional relationship between those critical process parameters and the critical quality attributes.

    This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated.

     

    Why you should attend:

     

    The Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers provides guidance on where design of experiments should be applied during process validation; it suggests the use of both screening and response surface designs during Operational Qualification. In addition, DOE should be used during multiple phases of design controls: design and development planning, design verification, design validation, design transfer, and design changes.

    In Guidance for Industry Q8 Pharamaceutical Development (as well as the annex to Q8), suggests applying experimental design to demonstrate "...an enhanced knowledge of product performance over a range of...process parameters." Using this "...enhanced, quality by design approach..." leads to greater system understanding. That greater system understanding has two elements: identifying critical process parameters and developing a functional relationship that link those critical process parameters to your critical quality attributes (CQAs). This suggests the use of both screening and response surface designs during pharmaceutical development studies.

    The need for DOE in product and process development is not only suggested, but imperative for both medical device and drug manufactures.

     

    Areas Covered in the Session:

     

    Learn how to effectively use JMP to:

             identify critical quality attributes (CQAs) that will be used as responses in your designs

             utilize risk management tools to identify and prioritize potential critical process parameters

             identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

             be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

             understand the need for adding center points to a design

             be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

             present results of DOE studies

             use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan

     

    Who Will Benefit:

     

    This webinar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design:

             Process Scientist/Engineer

             Design Engineer

             Product Development Engineer

             Regulatory/Compliance Professional

             Design Controls Engineer

             Six Sigma Green Belt

             Six Sigma Black Belt

             Continuous Improvement Manager

     

     

    Agenda:

     

     

    Day 1 Schedule

     

    Lecture 1:

    Primer on Statistical Analysis

    • basic statistics
    • two-sample t-test
    • ANOVA
    • regression

    Lecture 2:

    Introduction to Design of Experiments (DOE)

    • steps to DOE
    • defining critical quality attributes (CQAs)/responses
    • identifying and prioritizing potential process parameters

    Lecture 3:

    Screening Designs

    • full factorial designs
    • 2k factorial designs

     

    Day 2 Schedule

     

    Lecture 1:

    Screening Designs (continued)

    • fractional factorial designs
    • D-optimal designs

    Lecture 2:

    Response Surface Designs

    • 2k factorial designs with center points
    • Central Composite Designs (CCDs)
    • Box-Behnken designs
    • I-optimal designs

    Lecture 3:

    Utilizing Systematic Understanding from DOE Studies

    • presenting results
    • control plan/risk management strategy

     

     

    Speaker

    Heath Rushing

    Co-founder and Principal, Adsurgo 

     

    Heath Rushing is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications, and long-term training plans in quality and statistics across a variety of industries to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences. As a Quality Engineer at Amgen, he championed statistical principles in every business unit. He designed and delivered a DOE course that immediately became the company standard required at multiple sites. Additionally, he developed and implemented numerous innovative statistical methods advancing corporate risk management, process capability, and validation acceptance criteria. He won the top teaching award out of 54 instructors in the Air Force Academy math department where he taught several semesters and sections of OR and statistics. Additionally, he taught Operations Research and simulation modeling at the Colorado School of Mines and designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.

     

    Location: Las Vegas, NV Date:  September 28th & 29th, 2017 and Time: 9:00 AM to 6:00 PM

    Venue:   DoubleTree by Hilton Las Vegas Airport   7250 Pollock Drive Las Vegas, NV USA 89119

     

    Price:

     

    Register now and save $200. (Early Bird)

    Price: $1,295.00 (Seminar Fee for One Delegate)

    Until August 20, Early Bird Price: $1,295.00 From August 21 to September 26, Regular Price: $1,495.00

    Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

     

    Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

    At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

    As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

    For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

     

    Contact us today!

     

    NetZealous LLC DBA GlobalCompliancePanel

    john.robinson@globalcompliancepanel.com  

    support@globalcompliancepanel.com 

    Toll free: 1-800-447-9407

    Phone: 1-510-584-9661

     Website: http://www.globalcompliancepanel.com

     

    Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901126SEMINAR?globaleventslist-September-2017-SEO

     

    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

    Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

    Follow us on Twitter: https://twitter.com/GCPanel

     

    Las Vegas, NV, United States
  • Sep 2017
    28
    Sep 2017
    29

    NetZealous DBA as GlobalCompliancePanel

    Course "Combination Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

     

    Overview:

    This seminar provides Professionals working in this area with

    • A thorough understanding of the complexities involved
    • All the relevant regulations and guidelines
    • Real life examples of how to register and maintain various types of combination products
    • Interfaces: Change Management and LCM
    • Compliant safety reporting for combination products
    • Documentation requirements and interfacing

     

    Why you should attend :

     

    Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.

    Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.

     

    Areas Covered in the Session:

     

    Documentation requirements and interfacing

    • Documentation requirements for combination products EU
    • Documentation requirements for combination products US
    • Interfacing, development, quality, regulatory
    • Managing third parties and document control.

     

    Who Will Benefit:

     

    • Regulatory Affairs
    • Medical Officers
    • Clinical Trial Managers

     

    Agenda:

     

     

    Day 1 Schedule

     

    Lecture 1:

    A high level overview to Combination Products

    Including an interactive group session reviewing individual expectations

    Lecture 2:

    Introduction to Drug/Device Regulations

    During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities. Regulatory Requirements for: US and EU

    Lecture 3:

    CE Marking, 510 K and PMAs general Overview

    • US and EU

    Life Cycle Management

    • Interfaces: Change Management
    • CTA applications
    • Annual reporting

    Lecture 4:

    CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercises

    Wrap up of day 1 & Q&A's

     

    Day 2 Schedule

     

    Lecture 1:

    Overview Combination product Regulation and CTD dossier requirments: EU and US (A comparative review)

    Lecture 2:

    Clarifying the regulatory requirements of combination products and addressing life-cycle management

    • Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products
    • Annual reports
    • Case studies

    Lecture 3:

    CASE STUDY 2

    Lecture 4:

    Compliant safety reporting for combination products

    • Taking into account your product's combined components when addressing adverse event reporting

    Documentation requirements and interfacing

    • Documentation requirements for combination products EU
    • Documentation requirements for combination products US
    • Interfacing, development, quality, regulatory
    • Managing third parties and document control.

    CASE STUDY 3

    Wrap up of day 2

    Final Q&A & Summary of 'working smart' with Combination Products

     

     

    Speaker

    Salma Michor

    PhD, MSc, MBA, CMgr, RAC 

     

    Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

     

    Location: Boston, MA Date:  September 28th & 29th, 2017 and Time: 9:00 AM to 5:00 PM

    Venue:   Embassy Suites Boston Logan Airport   207 Porter Street Boston, MA 02128

     

     

    Price:

     

    Register now and save $200. (Early Bird)

    Price: $1,295.00 (Seminar Fee for One Delegate)

    Until August 10, Early Bird Price: $1,295.00 From August 11 to September 28, Regular Price: $1,495.00

    Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

     

    Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

    At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

    As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

    For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

     

    Contact us today!

     

    NetZealous LLC DBA GlobalCompliancePanel

    john.robinson@globalcompliancepanel.com  

    support@globalcompliancepanel.com 

    Toll free: 1-800-447-9407

    Phone: 1-510-584-9661

     Website: http://www.globalcompliancepanel.com

     

    Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901066SEMINAR?globaleventslist-September-2017-SEO

     

    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

    Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

    Follow us on Twitter: https://twitter.com/GCPanel

     

    Boston, MA, United States

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