Conferences and Meetings on Regulation in Medicine and Pharmacology

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1
FDA Recalls - Before You Start, and After You Finish
03 Aug 2017 - 04 Aug 2017 • Salt Lake City, United States
Abstract:
FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that,
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA Recall, FDA recall classes, FDA recall guidance, FDA recall procedures, regulatory management, CAPA, FDA inspection, Recall Regulations, Mandatory recall actions
Event listing ID:
885031
2
How to prepare a 510(k) Notification and a Technical File for the CE Mark
03 Aug 2017 - 04 Aug 2017 • San Diego, United States
Abstract:
For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA refuse to accept policy, special 510(k) submissions, traditional, 510(k) submissions
Event listing ID:
914018
3
Sample Size Justification & Statistical Analysis for Performance Qualification (PQ) Studies
17 Aug 2017 - 18 Aug 2017 • San Francisco, United States
Abstract:
Regulatory agencies mandate formal protocols for Performance Qualification (PQ) studies to determine whether products/processes meet the desired requirements. When planning PQ studies, sample size determination is critical to ensure that study results will be meaningful. Methods to determine appropriate sample sizes for various types of problems will be covered. This 2-day seminar will provide a 12-step process to assist you in writing/reviewing protocols for PQ studies with a focus on sample size justification, acceptance criteria and statistical analysis using Minitab v17. Validation of software will not be covered. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
statistical analysis for performance qualification (PQ) Studies, protocols for performance qualification (PQ), size justification
Event listing ID:
916117
4
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:
911392
5
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:
914017
Related subject(s):
6
Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
24 Aug 2017 - 25 Aug 2017 • Philadelphia, United States
Abstract:
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Latin America regulations, Latin America life sciences regulations, Latin America pharmaceutical regulations
Event listing ID:
916072
7
Basic Compliance Academy
11 Sep 2017 - 14 Sep 2017 • Philadelphia, PA, United States
Abstract:
HCCA's Basic Compliance Academy is a three-and-a-half-day intensive training program focusing on subject areas at the heart of health care compliance practice. Its faculty is made up of experts in the field. Courses are designed for participants who have a basic knowledge of compliance concepts and some professional experience in a compliance function.
Contact:
HEALTH CARE COMPLIANCE ASSOCIATION;     Phone: [service@hcca-info.org];     Email: 888-580-8373
Topics:
Policies, Procedures and Infrastructure, Corporate Responsibility, Risk assessment, Education and Training, Routine Auditing and Monitoring, Stark and Anti-Kickback, HIPAA Privacy and Security, Conflicts, Discipline & Incentives
Event listing ID:
913784
8
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
12 Sep 2017 - 13 Sep 2017 • Boston, United States
Abstract:
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated. Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance
Event listing ID:
885085
9
Analytical Instrument Qualification and System Validation
14 Sep 2017 - 15 Sep 2017 • Cambridge, United States
Abstract:
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Analytical Instrument Qualification, system validation process, operational qualification, instrument qualification, validation planning
Event listing ID:
926503
10
Root Cause Analysis and CAPA using 8-D Problem Solving Method
14 Sep 2017 - 15 Sep 2017 • San Francisco, United States
Abstract:
Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not recur. One of the most widely-used tools is the 8 Disciplines (8D) methodology. 8D requires you to identify and fix the problem immediately (put a bandaid on it) while identifying the Root Cause(s), and take steps to address the problem in the short term as well as in the long term (permanent fix). In this interactive workshop, you’ll learn how to apply the many tools used to identify possible causes, determine (with data) which is the true root cause (or causes, as there may be some compounding of problems occurring), and how to fix them – permanently. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
8-D Reporting, Reporting and Problem-Solving Technique, Root Cause Analysis, 8 Disciplines (8D) method, 8D framework, 8D technique, Root Cause Analysis (RCA)
Event listing ID:
926491
11
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:
885051
12
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:
876646
13
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:
904165
Related subject(s):
14
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:
926490
15
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:
912955
Related subject(s):
Event website:
16
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:
904219
Related subject(s):
17
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:
911798
18
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:
877317
19
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:
913797
20
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:
885094
21
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:
912878
22
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:
913983
23
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:
918804


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Last updated: 18 July 2017