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Online courses

ABOUT THE COURSE Want to learn all the elements of Tableau Desktop 10? You have come to the right place. Simpliv’s Tableau Certification Training will familiarize you with everything about Tableau, including visualizing, data organization and dashboard designing. Our course will ensure that you also don’t get left out of other concepts of Tableau, such as mapping, data connection and statistics. Ideal for system administrators, business intelligence professionals and software developers, Simpliv is all geared to put you on the road to Tableau Desktop 10 Qualified Associate certification. Who is the target audience?  All the professionals who are passionate about business intelligence, data visualization, and data analytics. Basic knowledge:  There are no prerequisi…

Online

Overview: This presentation will provide participants with a full understanding of the Theory of Mind and how it relates to Asperger Syndrome/High Functioning Autism. This concept can help explain why many individuals with this diagnosis act the way they do. Participants will learn of Baron-Cohen's attempt at assessing the Theory of Mind through the "Sally-Anne Test" and why this testing technique often creates a false negative allowing one to assume the skill is present when in reality it isn't.  You will understand why this test doesn't provide the necessary information needed to address the core social deficits of this population. You will learn how perspective taking is a fundamental concern when treating Asperger Syndrome/High Functioning Autism.  Participants wi…

Fremont, Alameda County, United States

This seminar will demonstrate how Covered Entities and Business Associates can comply calmly, confidently and completely with the HIPAA Rules. The secret is - HIPAA Rules are easy and routine to follow - when you know the steps.  Paul Hales will capture your attention with visual presentations and interactive learning exercises that take mystery and fear out of HIPAA Compliance.   Why you should attend In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time. HIPAA compliance takes time. But both goals can be accomplished - in fact, a good c…

Online courses

ABOUT THE COURSE Passionate about Python programming? The Information Technology world is waiting for you. This wonderfully flexible, object-oriented language is best learnt when it is learnt with examples. Simpliv offers tons of examples to help you understand the concepts and learn how to implement them in real life to integrate systems. Our course offers you knowledge of how to put Python to the highest use it is capable of being put to: web development, GUI, software development, system admin, and what not. Ideal for anyone who wants to put Python to its optimal use.. Who is the target audience?  Programmers, Developers, Technical Leads, Architects, Freshers,Data Scientists, Data Analysts,Business Intelligence Managers.   Basic knowledge: You don’t need any…

York, York, YO10 5DD, United Kingdom

Patient-reported outcomes (PROs) are increasingly being used both in the pharmaceutical industry, as well as in the National Health Service (NHS) and the public sector to capture the impact of healthcare interventions from the patient perspective. PROs have their distinct use in the private and public sector. For instance, in sponsored clinical trials PROs may be used to capture potential patient benefits of new medicinal products. On the other hand within the NHS, patient-reported outcomes and experiences are routinely recorded for a number of surgical procedures to measure the impact and quality of care received, health-related quality of life (HRQOL). However, despite these differences there is a considerable degree of overlap in the use of PROs in these sectors. This one-day cour…

Online

Overview: This webinar is designed to teach participants how to utilized MBSR techniques as a means to reduce stress and burnout, promote positive workplace functioning, and improve job satisfaction and productivity.  Why should you Attend: The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! Areas Covered in the Session: Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? Who Will Benefit: Regulatory Compliance and Regulatory Affairs Quality Management Sys…

Online

Overview: Attendees will be presented with an overview of the audit trails within an application and the content of each one, Also Attendees will be presented with a list of records to identify if they are GMP records. Why should you Attend: The regulatory concern has been responded to by both domestic and foreign governing agencies with the FDA, EMA, MHRA, WHO, and PIC/S all having recently published data integrity standards and guidelines. Areas Covered in the Session: File format Storage media Encryption User management (access control) Review of the data life cycle Handling of raw data Unauthorized access Who Will Benefit: Production Engineering & Validation Facilities / Maintenance Quality Assurance Regulatory Affairs Speaker Profile: Kelly Thomas has ov…

94-99 High Holborn, London, Greater London, WC1V 6LF, United Kingdom

CLINICAL TRIAL ADMINISTRATOR (CTA)Clinical Trial Administrator (CTA) is a trained professional who helps to facilitate a clinical trial. As a CTA you will primarily manage the administrative aspects of a number of clinical trials for every stage of the process.Accredited classroom based training - Duration 3 days. The role of the CTA will be covered in intensive detail with visual aids and hands-on training provided by experienced industry professionals.strong>Responsibilities Act as the pivotal point of contact and support for the clinical team. Assist the team with all aspects of administration to ensure the smooth running of the clinical trial programme.Set up, maintain and manage the trial master file (TMF) (e-TMF and or Paper TMF) in accordance with GCP.Set up, maintain and ma…

Online

Overview: Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality. Why should you Attend: Learn how OneNote can make you more productive while helping you to manage your meetings, your projects and your life. Areas Covered in the Session: Best Practice for Creating a Notebook Restructuring and Rearranging a Notebook Protecting your Information Using OneNote as a Task Management Tool Using OneNote for Internet Research Who Will Benefit: Business Professionals Business Owners Researchers Administration Support Staff Educators Speaker Profile: Mike Thomas has worked in the IT training business since 1989. He is a subject matter expert in a range of technologies including Microsoft Office and Apple Mac. In 201…

Online

Overview: In this webinar you will Learn how to navigate through FDA requirements, Ways to manage your presence in social media, How to identify an off-label problem and corrective action. Why should you Attend: Limitations on commercial free speech Avenues of off-label information Social media and your regulatory responsibilities Correcting off-label information Factoring in cognitive psychology Areas Covered in the Session: Learn to navigate through FDA requirements Understand that your right to free speech is limited How to get around FDA prohibitions Ways to manage your presence in social media Who Will Benefit: Regulatory Directors Marketing Directors Quality Systems Auditors Recall Managers In-house Legal Counsel Speaker Profile: Casper (Cap) Uldriks, thro…

Online

Overview: This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals. Why should you Attend: Understand the definition and scope of human factors Recognize the benefits of user centred design Identify opportunities where HF may improve current processes and designs Discuss the regulatory environment in several jurisdictions Areas Covered in the Session: What is human factors? What is covered by human factors? What is the purpose of human factors? Integration of human factors within the design process Who Will Benefit: Strategic and Operational Decision Makers within Complex Systems Engineers involved in the Development of control Systems…

Online

Overview: This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems. Why should you Attend: This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place. Areas Covered in the Session: FDA Regulatory Trends FDA Response to Change Recent FDA findings for companies in regulated industries Recent trends in technology that need to be addressed in the CSV approach Industry Best Practices Who Will Benefit: Clinical Data Scientists Analytical Chemists Compliance Managers Laboratory Managers Automation Analysts Manufacturing M…

94-99 High Holborn, London, Greater London, WC1V 6LF, United Kingdom

CLINICAL RESEARCH ASSOCIATE (CRA)A clinical Research Associate (CRA) primarily manages the managerial aspects of a number of clinical trials, at every stage of the process.Accredited classroom based training - Duration 3 days. The role of the CRA will be covered in intensive detail with visual aids and hands-on training provided by experienced industry professionals.This is fundamentally a “practical” and “hands on” workshop that focuses on current practice to ensure the CRA delegate develops practical experience of the role. Participants will learn about the role and responsibilities of the clinical research associate in the context of the regulations and rules that govern clinical trials.ResponsibilitiesIdentification of Investigator and selection of sites to participate in a clinic…

Online

Overview: NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts. Why should you Attend: These can be hand-held, lab-based, or installed in process lines This webinar will explain the manner in which NIR works, the equipment available, and the applications where it may best be used.  After this webinar, you will be able to evaluate which type of NIR would be best for your application How to generated samples for the calibration and validation of NIR instruments How to maintain and update NIR equipment and measurement equations Areas Covered in the Session: What are the types of hardware available? Why are they so different and why does each have differ…

Online

Overview: Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based? Areas Covered in the Session: Is the process "risk based"? K-97-1 and the FDA's "Decision Tree" Documenting the process / rationale Resolving a "wrong decision" Who Will Benefit: Senior Management, Project Leaders, Internal / External Consultants Regulatory Affairs Quality Systems Personnel / QAE R&D and Engineering Staff Speaker Profile: John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. Event Fee: One Dial-in One Attendee Price: US$150.00 …
21-Mar-2019 - 22-Mar-2019

16, Rennweg, Wien, 1030, Austria

Join our CMC Biopharma MasterClass on 21st and 22nd March, 2019 in Vienna, Austria! This CMC Biopharma MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as illustration and proper time will be allowed for discussion designs and outcomes.   By the end of the MasterClass, the participants…
21-Mar-2019 - 22-Mar-2019

16, Rennweg, Wien, 1030, Austria

This CMC Biopharma MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as illustration and proper time will be allowed for discussion designs and outcomes.   By the end of the MasterClass, the participants will understand:  • Process development strategies • Analytical and Formulation development • GMP manufacture • Proc…

Online

Overview: In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting. Why should you Attend: This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Areas Covered in the Session: How to prepare for an FDA inspection Development and contents of an SOP for FDA inspection Personnel training before inspection How to behave during an inspection Limitations of scope of inspection Response to investigation findings Who Will Benefit: Executive/senior management Regulatory management QA management Any personnel who may have direct interaction wit…

CTC Offices

Highly interactive course with a balance of information, workshops, exercises and quizzes offering a general overview of the drug development process including relevant tasks and responsibilities within the clinical research setting. It provides details on how drugs are developed and who the key players in the process are, about the terminology used in the clinical research environment and what rules, guidelines and laws are essential. How a clinical study is set up and performed and how to handle the documentation required in clinical research.
03-Apr-2019 - 03-Apr-2019

CTC Offices

The course offers a general overview of the drug development process and most relevant tasks and responsibilities within the clinical research setting It provides details on how drugs are developed and who the key players in the process are, about the terminology used in the clinical research environment and what rules, guidelines and laws are essential. How a clinical study is set up and performed and how to handle the documentation required in clinical research.