Conferences and Meetings on Regulation in Medicine and Pharmacology

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1
FDA's Medical Device Software Regulation Strategy
21 Sep 2017 - 22 Sep 2017 • Boston, United States
Abstract:
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance
Event listing ID:
885073
2
22nd International Conference of FFC- Functional Foods and Chronic Diseases: Science and Practice
22 Sep 2017 - 23 Sep 2017 • Boston, United States
Abstract:
Functional Food Center is pleased to announce its 22nd International Conference
Contact:
Email: ffc@functionalfoodcenter.com
Topics:
functional foods, chronic diseases, diabetes, CVD, obesity, cancer
Event listing ID:
876635
3
Biosimilars & Biobetters 2017
27 Sep 2017 - 28 Sep 2017 • London, United Kingdom
Abstract:
SMi Group are thrilled to present the 2017 8th annual conference on Biosimilars & Biobetters taking place on 27th & 28th September in Central London, UK. As the patents for several innovator biologics expire, biopharmaceutical companies are taking the opportunity to develop more affordable forms creating a rapidly booming biosimilars market. However, as the field of biosimilars evolves, challenges in immunogenicity studies, securing market share, exclusivity and regulations still persist. Created with a top panel of industry thought leaders, Biosimilars & Biobetters 2017 will tackle these challenges head on by honing in on current market trends, emerging opportunities and global developments. Join us this autumn to arm yourself with the key requirements and tools for successful market entry through strategic direction on commercialisation; insight into potential therapeutic areas; and critical updates on interchangeability guidelines and patient litigation.

A must attend for principle scientists and regulatory experts involved in biotechnology, market access and compliance, this years event will feature expert insight from Boehringer Ingelheim, Celltrion Healthcare, QuintilesIMS, Merck Group, Norwegian Medicines Agency, Teva Pharmaceuticals, Biocon, Gedeon Richter, Prolong Pharmaceuticals, Lupin Europe and more!

Contact:
Teri Arri;     Phone: [+44 (0)20 7827 6000];     Email: tarri@smi-online.co.uk
Topics:
biosimilars, biobetters, conference, regulatory, patent, us market, generics, pricing and reimbursement, market access, commercialisation, EU, global developments, emerging markets, pharmacovigilance, protein characterisation, analytical comparability, approval, immunogenicity, pqa, product quality assessment, comparative analysis, pricing and reimbursement, p&r, litigation, , European regulation, biogenerics, IP, intellectual property, data protection, supplementary protection certificate, payer
Event listing ID:
904198
Related subject(s):
4
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
28 Sep 2017 - 29 Sep 2017 • New Jersey, United States
Abstract:
It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA audit seminar, quality assurance practices, internal audit, vendor audit, third party audit, regulatory audit, CAPA programs
Event listing ID:
926545
5
Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016)
02 Oct 2017 - 03 Oct 2017 • Oakland, United States
Abstract:
Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Event listing ID:
932126
Related subject(s):
6
GLP Comparison with GMP in Quality System -2017
04 Oct 2017 • online, United States
Abstract:
Good Laboratory Practice (GLP) is a quality system which intend for non-clinical studies and was revised by several bodies. GLP is a unique quality system in the sense it is intend for non-routine processes and activities.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Veterinary Companies, Study Directors, Laboratory Managers
Event listing ID:
936116
7
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:
912966
Related subject(s):
Event website:
8
What are Standards for Medical Device Software -2017
10 Oct 2017 • online, United States
Abstract:
With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Business Analysts, Requirements Analysts, Product Managers
Event listing ID:
936115
9
Laboratory Have an Instrument Calibration Program -2017
10 Oct 2017 • online, United States
Abstract:
This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation, but necessary for an effective calibration program, such as instrument classifications.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Laboratory Managers, Laboratory Supervisors, Laboratory Analysts, Quality Assurance Managers
Event listing ID:
936070
10
Compliance for Computer Systems Regulated by FDA - 2017
10 Oct 2017 • online, United States
Abstract:
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Analytical Chemists, Laboratory Managers, Automation Analysts
Event listing ID:
936157
11
Cybersecurity and Computer Systems Validation - 2017
11 Oct 2017 • online, United States
Abstract:
Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Validation Engineers, Validation Project Managers, Program/Project Managers
Event listing ID:
936123
12
Pharmaceutical Pricing and Market Access
11 Oct 2017 - 12 Oct 2017 • London, United Kingdom
Abstract:
SMi Group presents the 23rd annual industry leading summit on Pharmaceutical Pricing & Market Access, 11 – 12 Oct 2017, London, UK. Pharmaceutical Pricing & Market Access 2017 will tackle industry challenges head on by preparing attendees to develop a successful market access strategy for the ever changing pharmaceutical and payer landscape. Join us this autumn for insight into how manufactures plan to limit further price increase; a progressive outlook into the future of pharmaceutical pricing & reimbursement (P&R); stakeholder collaboration; meaningful patient engagement opportunities; and discuss what can be done for the industry to achieve efficient reimbursement and for patients to gain access to affordable medication. Highlights will include an exclusive opening keynote from the FDA and interactive training on Real World Evidence (RWE). Featured Speakers include: Lundbeck, FDA, Shire, Sobi, Teva, Grifols, Allergan, Sanofi and more!
Contact:
Teri Arri;     Phone: [+44 (0)20 7827 6000];     Email: tarri@smi-online.co.uk
Topics:
Pharmaceutical Pricing & Reimbursement, market access, AMNOG, orphan drugs, biosimilars, brexit, NICE, P&R, premarket, postmarket, strategy, price, affordable, economic, payer, value proposition, disease, patient engagement, emerging market, real world data, RWE, real world evidence, medicine, drug, HTA, regulation, regulatory, orphan drugs, rare diseases, external affairs, FDA, regulatory review, translational, commercial, biopharma, international reference pricing, IRP, currency, value, stakeholder, fund, invest, budget, cost, accelerated access review, AAR, , value, value based pricing, therapeutic, health economic, positioning, commercial, viability
Event listing ID:
904208
Related subject(s):
13
Batch Record Review and Product Release - 2017
13 Oct 2017 • online, United States
Abstract:
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Quality Assurance, Batch Record Reviewers, Production Personnel
Event listing ID:
936155
14
2nd European Symposium on The New Agreed Draft Regulations on Medical Devices
16 Oct 2017 - 17 Oct 2017 • Berlin, Germany
Abstract:
Following the success of the first inaugural Congress in Prague, this second congress will address the important updates for Medical Devices.
Event listing ID:
911721
15
Medical Device Engineering Change Control - 2017
17 Oct 2017 • online, United States
Abstract:
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
QA/ QC Personnel, Engineering Management, Regulatory Personnel
Event listing ID:
936143
16
Analytical Instrument Qualification and Validation Processes - 2017
17 Oct 2017 • online, United States
Abstract:
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Process Owners, Quality Engineers, Quality Auditors
Event listing ID:
936175
17
PHARMATechExpo — VIII International Exhibition of Equipment and Technologies for the Pharmaceutical Industry
17 Oct 2017 - 19 Oct 2017 • Kiev, Ukraine
Abstract:
The only one Exhibition in Ukraine where is presented the entire pharmaceutical production process: from development of substances and quality control of raw materials, equipment for pharmaceutical production and packaging technologies to transportation, storage of pharmaceuticals and staff recruitment. During the exhibition, in the framework of the scientific-practical program Days of pharmaceutical industry will be held conferences, seminars, round tables and presentations.
Contact:
Olga Babii;     Phone: [+380442061015];     Email: expo@pharmatechexpo.com.ua
Topics:
raw materials and components, production and nonproduction equipment, packing and packing equipment, сlean rooms technologies, technologies and equipment for water supply, water treatment and sewage treatment, industrial refrigeration and climatic equipment for pharmaceutical enterprises, staff training and educational institutions, services for pharmaceutical companies
Event listing ID:
877251
18
How to Develop the Risk Management File - 2017
18 Oct 2017 • online, United States
Abstract:
The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of your risk management process will suffer.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Top Management, R&D Managers, Risk Managers
Event listing ID:
936163
19
483 Covers a Broad Gradation of Problems
25 Oct 2017 • online, United States
Abstract:
How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides proper documentation.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Manufacturers, FDA Consultants, Legal Counsel
Event listing ID:
936228
20
NIST Cybersecurity Framework For Computer Systems Validation
25 Oct 2017 • online, United States
Abstract:
Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Validation Engineers, Validation Project Managers, Program/Project Managers
Event listing ID:
936194
21
Healthcare Enforcement Compliance Institute
29 Oct 2017 - 01 Nov 2017 • Washington, DC, United States
Abstract:
Learn best and leading-edge practices for those involved in regulatory compliance at the Healthcare Enforcement Compliance Institute. The conference education will go beyond legal analysis to implementing systems to ensure the law is followed. You will be provided practical advice from lawyers and compliance officers in an interactive forum that facilitates greater collaboration between the legal and compliance teams. Get the latest legal analysis of various regulations and learn what you need to do to ensure you're in compliance with all the regulations and working most efficiently. Discover and discuss the latest trends in regulatory changes. Learn from experts focused not on legal discussions but dedicated to sharing the latest and best practices for implementing an effective compliance program that finds and fixes problems. Attend sessions focused on False Claims Act, Kickback, Stark Law, Criminal Healthcare Fraud and Internal Investigations.
Contact:
HEALTH CARE COMPLIANCE ASSOCIATION;     Phone: [888-580-8373];     Email: service@hcca-info.org
Topics:
False Claims Act, Kickback and Stark Law, Hospice and Nursing Homes, Criminal Healthcare Fraud, Compliance Program, Internal Investigations
Event listing ID:
913764
22
Guidance on Software and Device Changes and the 510(k)
30 Oct 2017 • online, United States
Abstract:
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Compliance Managers and Auditors, Lab Managers and Analysts, Automation Analysts
Event listing ID:
936160
23
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)
07 Nov 2017 - 08 Nov 2017 • San Francisco, United States
Abstract:
This interactive one-and-a-half-day seminar is intended to educate regulatory and quality professionals regarding the rather complicated regulations that distinguish Non-prescription Drugs from other products such as foods, cosmetics, dietary supplements and prescription drugs that sometimes contain the same ingredients. Recent FDA actions such as the banning of antibacterial soaps and ongoing programs that may impact manufacturers and private label distributors will be discussed. It will explain differences in the way homeopathic and conventional drugs are regulated and update participants on FDA’s application of GMP regulations to manufacturing low risk drugs that could be sold as cosmetics with the same ingredients, but different labeling. Note: Use coupon code REFERRAL10 and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Cosmeceuticals, dietary supplements, cosmetics, homeopathic OTCs, FDA regulations, FDA GMPS, good manufacturing practices
Event listing ID:
932182
Related subject(s):
24
Pharmacovigilance — 14th Pharmacovigilance 2017
09 Nov 2017 • Mumbai, India
Contact:
Kavitha;     Email: kavitha@virtueinsight.co.in
Topics:
PV legislation: What are the next steps? Reflections from the commission, IMA and the industry. How to improve pharmacovigilance activities? Creating a PV-focused culture How can you achieve pragmatism environment in today's PV? Pharmacovigilance and enabling technologies: which business model in a fast changing world? Opportunity that can reduce financial risk and increase effectiveness Pharmacovigilance Inspection Readiness Risk Minimization and effectiveness evaluation Business partners and exchange of safety data Optimising Drug Safety through Research Based Pharmacovigilance Launching a digital app in India for reporting ADRs: first results PV automation for data processing - Can Artificial Intelligence be trusted How social media can be used for pharmacovigilance syste Barriers to adopting AI and automation Patient view: the influence of real-time patient ratings and reviews of medicines and healthcare, and how this will shape the future of pharmacovigilance Proactively accomplish drug safety through patient engagement The challenges of the Indian Regulation – How to adapt and when? Required undergo registration process with CDSCO & DCGI
Event listing ID:
936048
Related subject(s):
25
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
09 Nov 2017 - 10 Nov 2017 • Cambridge, United States
Abstract:
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena. What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA training seminar, FTC advertising seminar, advertising drugs, advertising medical devices, promotion drugs, promoting medical devices, FTC advertising rules
Event listing ID:
885116
26
Quality Control Laboratory Compliance - cGMPs and GLPs
09 Nov 2017 - 10 Nov 2017 • San Francisco, United States
Abstract:
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals. This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs). Note: Use coupon code REFERRAL10 and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Quality Control Lab regulations, QC Lab regulations, FDA QC Lab requirements, FDA lab regulations, Good Laboratory Practices
Event listing ID:
932247
Related subject(s):
27
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
09 Nov 2017 - 10 Nov 2017 • San Francisco, United States
Abstract:
The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Note: Use coupon code REFERRAL10 and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
PV Audit Strategy Planning, The European Medicines Agency's (EMA) Guideline, Good Pharmacovigilance Practices (GVP), risk-based audits
Event listing ID:
932180
Related subject(s):
28
Biosimilars North America — 4th Annual Biosimilars North America Conference
15 Nov 2017 - 16 Nov 2017 • Iselin, United States
Abstract:
The market for biosimilars in North America continues to grow and has become highly lucrative. As such, pharmaceutical companies continue to find ways to differentiate their products in such a saturated market. Thus, Biosimilars North America 2017 will provide an intelligent meeting to explore novel and innovative strategies to advance biosimilar development, and ensure optimal market access and commercialization opportunities whilst complying with evolving regulatory requirements. This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.
Contact:
Honey de Gracia;     Phone: [02078276102];     Email: hdegracia@smi-online.co.uk
Topics:
Biosimilars, Interchangeability, Innovator, biosimilar commercialization, Immunogenicity, Pricing, Market Growth, generics, biosimilar market, biogenerics, biosimilar interchangeability guide, FDA, regulatory updates, drug development, biobetters, drug discovery, drug design,
Event listing ID:
912845
29
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
07 Dec 2017 - 08 Dec 2017 • Research Triangle, United States
Abstract:
One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA SOP requirements, FDA SOPs, FDA regulated industry SOP types, FDA SOP components, SOP training, SOP implementation, SOP template
Event listing ID:
914027
30
COLD CHAIN — SMi's 12th annual Cold Chain Distribution Conference and Exhibition
13 Dec 2017 - 14 Dec 2017 • London, United Kingdom
Abstract:
As the global healthcare industry grows, temperature controlled logistics rapidly evolves along with it. Factors such as the ever-changing regulatory requirements, diverse array of biopharma products entering the markets, and new technology emerging daily, are causing companies to face the challenge of constantly adapting their supply chain processes and staying ahead of the curve. Responding to the evolution within the industry, SMi is proud to announce the return of its leading 12th annual Cold Chain Distribution event. Returning to London in December, this year's event will remain at the forefront of innovation. With huge interest from leaders in the field, we have worked closely with an expert panel of speakers to present an agenda that is shaping up to be the best Cold Chain Distribution event. This year's event will continue to lead with its unrivaled panel of experts bringing you the most insightful presentations from our confirmed Industry-leading speakers from: Exelsius, Sanofi Genzyme, World Courier, Modalis, Eli Lilly, EMBALL'ISO, GlaxoSmithKline, World Health Organization, European Association of Pharmaceutical Full Line-Wholesalers (GIRP), National Institute for Biological Standards And Control, SeerPharma (UK), Merck SpA and many more!
Contact:
Kyra Williams;     Phone: [2078276012];     Email: kwilliams@smi-online.co.uk
Topics:
GDP Guidelines, Cold Chain Distribution, Temperature Control, Supply Chain, Logistics, Temperature Monitoring, Stability Studies
Event listing ID:
918815


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Last updated: 10 August 2017