Conferences and Meetings on Clinical trials

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1
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
10 Aug 2017 - 11 Aug 2017 • San Francisco, United States
Abstract:
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA GMP workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management
Event listing ID:
916030
2
FDA 510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
24 Aug 2017 - 25 Aug 2017 • Chicago, United States
Abstract:
Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.
Contact:
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics:
FDA 510(k) Seminar, 510(k) submission, FDA 510(k) Clearance, 510(k) Regulations, FDA 510(k) Workshop, 510(k) Application, 510(k) Strategy, , 510(k) Listing, , 510(k) Filing, 510(k) Approval, Class 1 and 2 Medical Device
Event listing ID:
911370
3
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
24 Aug 2017 - 25 Aug 2017 • San Francisco, United States
Abstract:
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
eCTD submission workshop, FDA eCTD submission training, CTD/eCTD format requirements, eCTD submission technical & document requirements
Event listing ID:
913940
4
Edinburgh CRF: Using Mixed Methods in Research
04 Sep 2017 • Edinburgh, United Kingdom
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Topics:
Mixed methods, research, clinical trials, WTCRF, quantitative, qualitative
Event listing ID:
898860
5
Edinburgh CRF: Helping you to Submit a Successful NHS Research Ethics Application
06 Sep 2017 • Edinburgh, United Kingdom
Abstract:
A half day of interaction with Research Ethic Committee (REC) members and staff providing an insight into the NHS ethical review process. Step-by-step guidance on the ethical review process including details on what to do before submitting an application, during the committee meeting and after gaining ethical approval. REC staff will provide advice on submitting the correct paperwork and their opinions on what information is required for a successful application.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
903935
Event website:
6
Edinburgh CRF: Stats for the Terrified (An Intro to Stats) & Making Sense of Numbers (Interpretation of data)
07 Sep 2017 • Edinburgh, United Kingdom
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899055
Event website:
7
Edinburgh CRF: How to be Well Read: Workshop on How to Read a Scientific Paper
12 Sep 2017 • Edinburgh, United Kingdom
Abstract:
An essential professional skill is being able to read the clinical and scientific literature in an efficient and critical way. Through a series of short presentations, many examples and interactive practical sessions this workshop is designed to explain the importance of the scientific literature, discuss the range of different kinds of scientific paper, explore the structure and function of the different portions of a paper and develop an attack strategy for readers.
Contact:
Phone: [013153773355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899021
Event website:
8
Edinburgh CRF: Data Management for Researchers
12 Sep 2017 • Edinburgh, United Kingdom
Abstract:
The collection, processing and analysis of data are at the heart of all research. For our research to be meaningful we must ensure that the data we collect are complete and accurate, recorded carefully and processed appropriately before they can be analysed. In this workshop, Allan Gaw will take delegates through the general principles of data management as they apply to research and will, through a series of examples, show how to put these principles into practice. Importantly, please note that this workshop will not cover any aspect of statistical analysis of research data and it will focus primarily on the collection and processing of quantitative data.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899031
Event website:
9
Edinburgh CRF: NRS Introduction to Good Clinical Practice (GCP)
13 Sep 2017 • Edinburgh, United Kingdom
Abstract:
This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented very much as a practical introduction to the subject and consists of a mixture of a series of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life. While the principles of the GCP that are covered in the course are common to a wide range of different types of clinical research the course does focus on the drug trial specific legislation. However, it also tries to promote the ‘GCP-mindset’ needed to satisfy inspectors and auditors, and would therefore be useful for all clinical researchers.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899063
Event website:
10
Edinburgh CRF: NRS Good Clinical Practice (GCP) Update
14 Sep 2017 • Edinburgh, United Kingdom
Abstract:
Experienced research personnel who have previously completed an Introduction to GCP.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899106
Event website:
11
Edinburgh CRF: Applying for Research Approvals in Lothian - Using IRAS
26 Sep 2017 • Edinburgh, United Kingdom
Abstract:
A half day training including presentations, practical computer sessions & discussions on how to apply for research approvals using the IRAS system. The Integrated Research Approvals System (IRAS) is now the only mechanism by which all applications to NHS research ethics committees are handled (as well most of the other main research approvals, including R&D and MHRA). Researchers who have in past applied for research approvals (ethics, R&D etc) but need a refresher, or who intend to apply for the first time, will benefit from this course.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
908033
Event website:
12
Edinburgh CRF: Meta-Research Short Course (3 day course)
27 Sep 2017 - 29 Sep 2017 • Edinburgh, United Kingdom
Abstract:
The purpose of this course is for students to understand the principles of meta-research and to develop skills in relation to research synthesis, meta-analysis and assessment of bias in biomedical research.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
903737
Event website:
13
NCCR 2017 - 11th National Conference for Clinical Research
27 Sep 2017 - 29 Sep 2017 • Putrajaya, Malaysia
Abstract:
This three-day event will provide a platform to gain insights and new findings from global thought leaders, researchers and stakeholders. This year’s focus will be on the advancement in precision medicine - the challenges and opportunities in this promising sector and updates in clinical research.
Contact:
Secretariat;     Phone: [+60377268000];     Email: confsec@crestevendz.com.my
Event listing ID:
880575
14
Edinburgh CRF: An Introduction to Qualitative Research Methods (3 day course)
29 Sep 2017 - 13 Oct 2017 • Edinburgh, United Kingdom
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Topics:
qualitative, research, clinical, trials, methods, data
Event listing ID:
898969
15
Edinburgh CRF: GCP for laboratories
09 Oct 2017 • Edinburgh, United Kingdom
Abstract:
This course is intended primarily for lab staff who handle human samples but is also suitable for research nurses and other staff who regularly process bloods, use centrifuges and store samples.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
911668
Event website:
16
Edinburgh CRF: Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection
10 Oct 2017 • Edinburgh, United Kingdom
Abstract:
Statutory GCP inspections conducted by the Medicines and Healthcare products Regulatory Agency (MHRA), are an important part of the regulation of clinical trials in the UK. Anyone who sponsors, conducts or supports a clinical trial in humans involving an investigational medicinal product (CTIMP) or a medical device may find themselves face-to-face with an MHRA inspector. What an inspector will be looking for is evidence that trials have been conducted in compliance with applicable legislation and the principles of GCP. It is a daunting prospect for many, but an understanding of what to expect and how to prepare can help smooth the process and lead to a successful inspection outcome.

This half-day course will use presentations and workshops to provide an overview of the GCP inspection process from notification to closure, along with some handy hints and tips for surviving the experience relatively unscathed. It is aimed at anyone who may be involved in an MHRA GCP inspection.

Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
912999
Event website:
17
Edinburgh CRF: Paediatric Consent: The Practicalities and Legalities in Taking Consent for Paediatric Trials
11 Oct 2017 • Edinburgh, United Kingdom
Abstract:
This course, delivered by solicitors from the Scottish Child Law Centre alongside experienced clinical researchers, examines the ethical, legal and practical considerations of obtaining consent for paediatric clinical trials. Using case studies, participants will be introduced to a variety of scenarios to facilitate discussion around the challenges and potential complexities faced during the consent process. During the course, participants will have the opportunity to relate theory to practice in small discussion groups. Suitable for all those involved in paediatric trials, the aim of the course is to provide participants with an improved knowledge of the subject and the confidence to apply best practice within their own work areas.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
912815
Event website:
18
6th International Conference on Clinical and Medical Case Reports
16 Oct 2017 - 18 Oct 2017 • San Francisco, United States
Abstract:
ICMCR 2017 cordially welcomes high quality late breaking abstract (case reports and clinical research) submissions in following specialties: Internal Medicine, Surgery and all sub specialties including Cardiovascular diseases, Gastrointestinal and Hepatic diseases, Respiratory disorders, Infectious diseases, Endocrine and metabolic disorders, Hematology, Musculoskeletal disorders, Allergy-Immunology, Oncology, Rare/Orphan diseases, Renal diseases, Rheumatology, Genetic disorders, Geriatrics, and Other.
Event listing ID:
911773
19
LABComplex — X International exhibition «LABComplEX. Analytics. Laboratory. Biotechnologies. Hi-Tech»
17 Oct 2017 - 19 Oct 2017 • Kiev, Ukraine
Abstract:
The only industry oriented event of Ukraine within which is presented whole range of equipment, technologies and specialized furniture, supplies as well as range of services for creation, equipping, modernization of all types and kinds of laboratories of various industries, scientific-research field and medicine.Specialists participated in conferences, seminars and master classes in the framework of the following scientific-practical programs: Days of food industry and agricultural sector, Days of pharmaceutical industry, Days of Veterinary Medicine, Days of Laboratory Medicine.
Contact:
Olga Babii;     Phone: [+380442061015];     Email: expo@labcomlex.com
Topics:
analytical equipment, laboratory instrumentation, laboratory equipment, mobile laboratories, laboratory furniture and utensils, tools and consumables, reagents, indicators, test-systems and reagents, personal protective equipment, protective clothing, integrated solutions required for laboratories of any profile.
Event listing ID:
876719
20
Edinburgh CRF: NRS Introduction to Good Clinical Practice (GCP)
24 Oct 2017 • Edinburgh, United Kingdom
Abstract:
This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented very much as a practical introduction to the subject and consists of a mixture of a series of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life. While the principles of the GCP that are covered in the course are common to a wide range of different types of clinical research the course does focus on the drug trial specific legislation. However, it also tries to promote the ‘GCP-mindset’ needed to satisfy inspectors and auditors, and would therefore be useful for all clinical researchers.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899127
Event website:
21
Edinburgh CRF: NRS Good Clinical Practice (GCP) Update
25 Oct 2017 • Edinburgh, United Kingdom
Abstract:
Experienced research personnel who have previously completed an Introduction to GCP.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899093
Event website:
22
Edinburgh CRF: The Write Stuff: A Short Scientific Writing Course (3 Day Course)
01 Nov 2017 • Edinburgh, United Kingdom
Abstract:
This short course consists of three half days spread over three weeks. During the time we have together we will develop and try out different strategies to help us write and we will look in detail at some of the specific writing tasks that we face in science. In particular, we will spend time on developing a strategy for writing a scientific paper.Because the course is over three weeks each participant will be invited after each session to prepare some short pieces of writing that will be individually critiqued by the course presenter Allan Gaw.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899169
Event website:
23
Edinburgh CRF: Putting it Together: Project Management in Clinical Research
02 Nov 2017 • Edinburgh, United Kingdom
Abstract:
A successful research project does not solely depend on an important research question and a well designed protocol, but also on the efficient execution of the project. Many research projects fail to complete on time and on budget and some struggle even to get off the ground. In this half-day workshop we will apply the principles of project management to clinical research and show how by applying some simple tools and techniques we can solve many of the common problems we face and avoid others altogether. The workshop will consist of a series of short, interactive lectures, interspersed with practical exercises.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
899179
Event website:
24
Edinburgh CRF: Informed Consent: Legal & Ethical Issues in Consent (Adults)
15 Nov 2017 • Edinburgh, United Kingdom
Abstract:
Informed consent is the foundation of all ethical research. This workshop will focus on the ethical, legal and practical issues around obtaining informed consent from adult individuals participating in clinical research projects. It will also cover consent issues relating to the use of human tissue and data in research. The workshop will consist of a mixture of short presentations, case studies and practical exercises. It is designed for anyone who is involved in clinical research, but especially for those who are involved in the informed consent process.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
912919
Event website:
25
Edinburgh CRF: NRS Introduction to Good Clinical Practice (GCP)
29 Nov 2017 • Edinburgh, United Kingdom
Abstract:
his one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented very much as a practical introduction to the subject and consists of a mixture of a series of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
913418
Event website:
26
Oncology Trials: Focus on Phase III
29 Nov 2017 - 30 Nov 2017 • London, United Kingdom
Abstract:
What is Oncology: Phase III Trials? Oncology: Phase III Trials is a two-day, rapid and progressive training programme.  Led by specialist physicians face-to-face learning equips delegates with the knowledge required to discuss Oncology Trials confidently and credibly. Oncology: Phase III Trials is a high calibre, two-day training programme presented in London, UK. This interactive and informative course provides a comprehensive overview of the planning and implementation of oncology clinical trials, focusing on Phase III. The course will demonstrate how oncology trials differ in design and conduct from those in other therapy areas. Delegates learn to design trials to minimise the deficiencies that lead to inappropriate interpretation whilst maximising the competitive advantage. Delegates will hear the perspective of currently practicing oncologists with extensive experience of industry clinical trials as well as professionals who will discuss oncology clinical trial statistics and oncology product market entry. What will I learn about oncology clinical trials? You have the opportunity to learn from experts: How oncology trials differ in design and conduct from those in other therapy areas, How to design trials to minimise the deficiencies that lead to inappropriate interpretation whilst maximising the competitive advantage, Practicing oncologists with extensive experience of industry clinical trials & professionals discuss oncology clinical trial statistics and oncology product market entry. Topics include: Introduction to oncology clinical trial design and planning, Informed consent/patient information, The impact of trials on clinical practice, Statistical analysis and reporting, Health economics assessment, Quality of life assessment. Faculty includes: Professor Allan Hackshaw, Deputy Director, Cancer Research UK & UCL Cancer Trials Centre, Cancer Institute, University College London, London, UK Mr Jim Furniss, SVP, Global Market Access, GfK Market Access, UK Professor Chris Twelves, Professor of Clinical Pharmacology and Oncology, St James’s Institute of Oncology, UK Is this oncology clinical trials course for me? Oncology: Phase III Trials is ideal for pharmaceutical, medical technology and biotechnology industry personnel working in the area of oncology. It is appropriate for those involved in clinical research, medical affairs and regulatory functions, as well as individuals in strategic marketing and business functions.
Event listing ID:
912110
Related subject(s):
27
Edinburgh CRF: NRS Good Clinical Practice (GCP) Update
30 Nov 2017 • Edinburgh, United Kingdom
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
913411
Event website:
28
2 Day course — Edinburgh CRF: Edinburgh Clinical Trials Management Course - ECTMC
30 Nov 2017 - 01 Dec 2017 • Edinburgh, United Kingdom
Abstract:
With a blend of lectures and workshops, and plenty of time to talk to fellow delegates, this course is relevant to people currently involved in managing RCTs and those new to this field. It's a mixture of education, information exchange, an opportunity for networking, with a pleasant dinner thrown in!
Event listing ID:
912153
29
Edinburgh CRF: NRS Introduction to Good Clinical Practice (GCP)
24 Jan 2018 • Edinburgh, United Kingdom
Abstract:
This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented very much as a practical introduction to the subject and consists of a mixture of a series of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
922696
Event website:
30
Edinburgh CRF: NRS Good Clinical Practice (GCP) Update
25 Jan 2018 • Edinburgh, United Kingdom
Abstract:
Experienced research personnel who have previously completed an Introduction to GCP.
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
922662
Event website:
31
The 2nd International Congress on Clinical Trials in Oncology and Hemato-Oncology
19 Feb 2018 - 20 Feb 2018 • Berlin, Germany
Event listing ID:
920953
Related subject(s):
32
Edinburgh CRF: NRS Introduction to Good Clinical Practice (GCP)
20 Feb 2018 • Edinburgh, United Kingdom
Abstract:
This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented very much as a practical introduction to the subject and consists of a mixture of a series of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
922738
Event website:
33
Edinburgh CRF: NRS Good Clinical Practice (GCP) Update
21 Feb 2018 • Edinburgh, United Kingdom
Abstract:
Experienced research personnel who have previously completed an Introduction to GCP.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
922712
Event website:
34
Edinburgh CRF: NRS Introduction to Good Clinical Practice (GCP)
28 Mar 2018 • Edinburgh, United Kingdom
Abstract:
This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented very much as a practical introduction to the subject and consists of a mixture of a series of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life.
Contact:
Phone: [01315373355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
922762
Event website:
35
Edinburgh CRF: NRS Good Clinical Practice (GCP) Update
29 Mar 2018 • Edinburgh, United Kingdom
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
922832
Event website:
36
Edinburgh CRF: GCP for laboratories
25 May 2018 • Edinburgh, United Kingdom
Abstract:
This course is intended primarily for lab staff who handle human samples but is also suitable for research nurses and other staff who regularly process bloods, use centrifuges and store samples. University of Edinburgh clinical research labs that analyse samples from Clinical Trials of Investigational Products (CTIMPs) i.e. drug trials, must comply with the principles of GCLP and these labs are open to inspection by the Medicines and Healthcare Products Regulatory Authority (MHRA).
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
924371
Event website:
37
Edinburgh CRF: GCP for laboratories
04 Oct 2018 • Edinburgh, United Kingdom
Abstract:
This course is intended primarily for lab staff who handle human samples but is also suitable for research nurses and other staff who regularly process bloods, use centrifuges and store samples. University of Edinburgh clinical research labs that analyse samples from Clinical Trials of Investigational Products (CTIMPs) i.e. drug trials, must comply with the principles of GCLP and these labs are open to inspection by the Medicines and Healthcare Products Regulatory Authority (MHRA). However, it is desirable for staff in any lab, or area that handles and stores human samples, to be aware of GCLP and comply as far as possible. This course, run by Alex MacLellan, Quality Assurance Manager, CRUK Tissue Group, Edinburgh, is based on the MHRA's document
Contact:
Phone: [0131 537 3355];     Email: wtcrf.education@ed.ac.uk
Event listing ID:
923179
Event website:


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Last updated: 10 July 2017