Conferences and Meetings on Regulation in Medicine and Pharmacology

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1
Auditing for Medical Device and Pharma Companies – A Tool to Reduce Quality and Compliance Risk
25 May 2017 - 26 May 2017 • Boston, United States
Abstract:
This 2-day seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well-planned audit program can reduce these risks. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Pharma and medical device internal auditing, internal audit program, FDA's expectations, documentation, risk analysis techniques, audit program structure
Event listing ID:
883869
2
The Veterinary Drug Approval Process and FDA Regulatory Oversight
01 Jun 2017 - 02 Jun 2017 • Kansas City, United States
Abstract:
The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA veterinary drug approval process, center for veterinary medicine, new animal drug application, investigational new animal drug (INAD) file, animal disease diagnostic devices, veterinary medicine regulations, veterinary drug user fees, Agriculture’s Animal and Plant Health Inspection Service
Event listing ID:
883835
3
Pre-Filled Syringes West Coast
05 Jun 2017 - 06 Jun 2017 • San Diego, United States
Abstract:
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.

Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry. The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices. We will also be welcoming expertise from the likes of Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon, Allergan, MedImmune, Xeris Pharmaceuticals, Amgen, Eli Lilly, Genentech, Ferring, Roche and more.

Contact:
Teri Arri;     Phone: [+44 (0)20 7827 6000];     Email: tarri@smi-online.co.uk
Topics:
prefilled syringe, pre-filled syringe, autoinjector, human factors, device development, innovation, strategy, extractables, leachables, patient safety, compliance, biosimilar, parenteral, packaging, combination products, lyophilisation, freeze drying, injectable, injectable devices, syringe, extractables and leachables, E&L, PFS, drug device, drug delivery, combination products, sterilization, needle, component, glass syringe, cop syringe, container, formulation, device development, human factors, manufacturing, device technology, medical device, parenteral drug, plastic, qbd, drug delivery, infusion, vial, cop, sterilization, clogging
Event listing ID:
877316
4
Applying the FDA Food Safety Modernization Act (FSMA) to Your Organization
08 Jun 2017 - 09 Jun 2017 • Minneapolis, United States
Abstract:
The Food Safety Modernization Act has introduced some of the most sweeping reforms to U.S. food safety laws in more than 70 years. It is mandated that all FDA regulated manufacturers in the United States and any foreign entity who produces food to be consumed within the US must comply to applicable final rules. This seminar offers a 360 degree view of food safety practices from a FSMA-centered approach. The courses will highlight the basics of food safety with an emphasis on compliance. The seminar will provide the tools needed to align your company’s governance, risk management, and compliance programs with new FDA regulations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FSMA, food safety modernization act, FSMA requirements, food-borne illness, HACCP, food safety, Hazard Analysis and Critical Control Points, FDA food compliance
Event listing ID:
883878
5
3rd Annual ComplianceOnline Medical Device Summit 2017
08 Jun 2017 - 09 Jun 2017 • Boston, United States
Abstract:
Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.

Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.

Build FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system.

Interact with leading minds in the industry. Attendees will get to network with the prominent decision makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities.

Deliberate the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process.

Scale factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs better understand the criterias for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses.

Enhance risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve quality management system.

Note: Use coupon code NB5SQH8N and get 10% off on registration.

Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Medical Device Summit, Medical Device Seminar, Medical Device Summit 2016, Medical Device Seminars 2016, Medical Device Conferences, Medical Device Events
Event listing ID:
884961
6
In Vitro Diagnostics
14 Jun 2017 - 15 Jun 2017 • London, United Kingdom
Abstract:
The third in its series, SMi is delighted to announce the return of In Vitro Diagnostics taking place in London on the 14th & 15th June 2017. Aimed at Managers/Heads and Directors of Regulatory Affairs, In Vitro Diagnostics, Clinical Affairs and Quality Assurance, IVDs 2017 will provide regulatory updates and key industry feedback from leading IVD manufacturers within this complex and ever-changing landscape. Through a series of presentations from handpicked industry experts and Notified Bodies, the 2017 event will prepare attendees for the challenging times ahead and how to comply with regulatory requirements to ensure direct access to market ensuring the continued growing demand for use and innovation of IVDs over the next decade and beyond. Topics of discussion include: Latest updates on the IVD regulation, the changing role of notified bodies as well as the increase in requirements for clinical evidence.
Contact:
Zoe Gale;     Phone: [02078276132];     Email: zgale@smi-online.co.uk
Topics:
in vitro, invitro, diagnostics, IVD, medical device, regulation, Notified Bodies, NB, IVDR
Event listing ID:
882674
7
The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
15 Jun 2017 - 16 Jun 2017 • Newark, United States
Abstract:
All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This lack of understanding of microbial control often leads to poor system designs, poor system sampling, poor system maintenance and poor sanitization practices, and as a result, ongoing microbial problems with the water. This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Pharmaceutical water systems seminar, water system compliance seminar, water system microbial control, water system microbial monitoring, water system validation
Event listing ID:
883855
8
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
15 Jun 2017 - 16 Jun 2017 • Boston, 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. This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. 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, SOP numbering system
Event listing ID:
883854
9
Designing and Sustaining New and Existing Product Stability Testing Program
15 Jun 2017 - 16 Jun 2017 • Orlando, United States
Abstract:
New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug products have made inadvertent mistakes in the design of their new drug stability testing program. Such mistakes may ultimately delay the new, existing or modified product IND or NDA application process due to the data that was presented to the FDA (i.e. Relevant aspects of the stability testing program requirement may have been omitted by the drug manufacturers). It is better to understand, follow and apply the full requirements of a new product stability testing requirement from the onset or to correct an existing stability testing program so as to avoid future pitfalls and delayed IND or NDA submission process by the FDA. Having produced a new or existing product, knowing the appropriate way to design and perform the stability testing of the new product which is a prerequisite for setting the product's expiration date and possible extension of the expiration date is critical. Some drug product manufacturers have made mistakes in the past whereby a new product that was manufactured appropriately did not have a good stability testing plan or program hence it delayed the product's ability to have an approved IND or NDA submission. A mistake of this sort has also been made by drug manufactures that resulted in a 483 or Warning letter by the FDA. Knowing how to approach the design of a new product stability program at the onset of the new product design or during an existing product testing is important and will save a company time and cost in moving the product to the next phase. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA's Drug Stability Testing Program, NDA submission, 21CFR 514.1(b)(5)(x) expectations, Analytical Testing Considerations, Laboratory Information Management Systems (LIMS)
Event listing ID:
883897
10
Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs
15 Jun 2017 - 16 Jun 2017 • San Francisco, United States
Abstract:
Pre-clinical or non-clinical studies are required during drug development to evaluate safety in animals (toxicology) and pharmacokinetics and bioavailability (pharmacology) of drugs prior to initiating the clinical development of a drug. These studies must be performed following the Good Laboratory Practices (GLP) regulations, specified by the US FDA or principles and guidelines developed by the Organisation of Economic Co-operation and Development (OECD). Regulations for the GLP, specified in 21 CFR 58, related guidelines, including “questions and answers” documents, a training handbook and training manuals developed by the World Health Organization (WHO) are available to clarify the regulatory expectations with a view to assisting the sponsors of drugs and contract testing laboratories performing toxicology and pharmacology studies in complying with these regulations. Despite these guidance documents and training materials, GLP regulations are one of the most commonly misunderstood regulations for drug development and manufacturing operations with a number of myths about GLPs. This course will explain various elements of GLPs in detail with a view to comply with the regulations and Law as per regulatory requirements and expectations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Drugs development requirement, bioanalytical methods, good laboratory practices, GLP, GMP, 21 CFR 58, GLP regulations, pharmacokinetics, bioavailability
Event listing ID:
883907
11
FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements
15 Jun 2017 - 16 Jun 2017 • New Jersey, United States
Abstract:
This course is intended for employees who need a basic understanding of the FDA rules and regulations for pharmaceuticals. It will cover the basics of various ways to bring a product to market as well as Current Good Manufacturing Practice (cGMP). Items to be discussed include Over-the-Counter (OTC) Monographs, New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), product development overview, Investigational New Drugs (INDs), concepts in clinical trials and bioequivalence trials, amendments and supplements to applications, analytical method and process validation, cGMPs and FDA Inspections. The course is not intended to prepare a student to create any of the matters discussed. Rather it is intended to give the student enough knowledge so that he or she can intelligently participate in discussions of strategy and assignment of resources. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA requirements for the pharmaceutical industry, FDA pharma compliance, current good manufacturing practice (cGMP), over-the-counter (OTC) monographs
Event listing ID:
883840
12
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
15 Jun 2017 - 16 Jun 2017 • San Francisco, United States
Abstract:
With the recent implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013, healthcare organizations are reviewing their compliance and making sure they have the proper policies, procedures, and forms in place. HIPAA Privacy Officers have been renewing their compliance activities and reviewing their documentation to make sure they can meet the challenges of the new rules and avoid breaches and penalties for compliance violations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
HIPAA privacy rule, HIPAA regulations, HIPAA compliance
Event listing ID:
883949
13
Managing Your FDA Inspection: Before, During and After
15 Jun 2017 - 16 Jun 2017 • San Diego, United States
Abstract:
FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. This course will help you need to know and what you should do to survive an FDA inspection with the least possible pain. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA inspection seminar, FDA inspection, FDA 483, FDA warning letter, FDA investigator, FDA law, Regulatory Sanctions used by FDA, Prohibited Acts
Event listing ID:
903541
14
Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
19 Jun 2017 - 20 Jun 2017 • Orlando, United States
Abstract:
This seminar will guide the attendee in effectively handling, addressing and remediating FDA's and other related compliance issues associated such as FDA's Form 483, Warning Letter and Consent Decree Compliance Findings. An effective handling and resolution of Compliance issues will prevent further disciplinary actions such as an FDA's Warning Letter or a formal Consent Decree which ends with a costly impact, fines and possible injunctions by the FDA. Because the impact of non-compliance and remediation of compliance issues are very costly, time consuming and impacting to a business and associated manufactured product including an increasing severity of disciplinary action by the FDA, understanding the triggers, effective preventative and corrective actions and an effective and expedient resolution of such compliance issues will assist a manufacturer of product in preventing expensive remediation of compliance issues, delays to product launch, impact on current commercially available product, overall business reputation, product recall, Fines, loss of impacted Product, loss of business licensure and/or prosecution by the FDA. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA Form 483 Warning Letters, FDA Consent Decree, FDA injunction, Code of Federal Regulations, FDA Form 483 Seminar
Event listing ID:
883915
15
FDA's New Import Program for 2017 - Strict Precision
22 Jun 2017 - 23 Jun 2017 • San Francisco, United States
Abstract:
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program became mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA import regulations, FDA’s import legal requirements, U.S. Customs and Border Protection, CBP requirements, FDA warning letter, FDA import program, risk of detention
Event listing ID:
885048
16
Human Factors and Predicate Combination Products
22 Jun 2017 - 23 Jun 2017 • San Francisco, United States
Abstract:
The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
human factors methods and best practices, role of Human Factors in FDA approval process, medical device design, medical device development, device product life cycle
Event listing ID:
903616
Related subject(s):
17
How to do Research on Therapeutic Interventions: Protocol Preparation
03 Jul 2017 - 07 Jul 2017 • Oxford, United Kingdom
Abstract:
The How to do Research on Therapeutic Interventions: Protocol Preparation course is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Grant D Vallance, Information Manager at the Oxford University Hospitals NHS Trust, and will feature face-to-face lectures and tutorials from some of Oxford's leading clinicians and scientists.
Contact:
Course Administrator;     Phone: [+44(0)1865 286955];     Email: expther@conted.ox.ac.uk
Event listing ID:
828787
Related subject(s):
18
Training — Clinical Audit Masterclass
07 Jul 2017 • London, United Kingdom
Abstract:
Clinical Audit Masterclass is a one-day course that provides delegates with a full understanding of the clinical audit process and includes information and advice on how to carry out clinical audit to an advanced level. The focus of this course is on undertaking high quality clinical audit that makes a difference! A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics:
Clinical Audit
Event listing ID:
905435
19
Statistical Analysis for Product Development
12 Jul 2017 - 13 Jul 2017 • San Francisco, United States
Abstract:
This course is designed to help scientists and engineers understand the statistical methods used in process and product development. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability. You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You will also learn to improve process output characteristics including quality, cost, and robustness through generating empirical models of your processes in the fewest experiments possible. This highly interactive course will allow participants the opportunity to develop strategies for analysis of experimental data. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own statistical methods to support the various stages of product development. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Statistical Analysis, product development, statistical methods, variability, design of experiments, systematic variability, special cause variability, analytical method development, process improvement, experimental budget
Event listing ID:
885025
20
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
13 Jul 2017 - 14 Jul 2017 • Minneapolis, United States
Abstract:
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
Event listing ID:
878083
Related subject(s):
21
Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies
13 Jul 2017 - 14 Jul 2017 • Irvine, United States
Abstract:
In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices. In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA regulatory oversight of HCT/Ps, tissue reference group, approval process, good tissue practice, good manufacturing practice, quality system regulations, good laboratory practice, FDA enforcement actions, adverse event reporting, homologous use, adipose tissue, translation medicine
Event listing ID:
885057
22
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
13 Jul 2017 - 14 Jul 2017 • Minneapolis, United States
Abstract:
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
Event listing ID:
885001
23
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
13 Jul 2017 - 14 Jul 2017 • Irvine, United States
Abstract:
Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications. This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Regenerative medicine regulations, Stem Cell Treatments, biomaterials, FDA regulates regenerative treatments and therapies, good manufacturing, good laboratory practices
Event listing ID:
885088
24
Supplier Management for Medical Device Manufacturers
13 Jul 2017 - 14 Jul 2017 • Cambridge, United States
Abstract:
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Supplier management, supplier selection, medical device manufacturers, FDA quality system regulations, ISO 13485 requirements, supplier classification system
Event listing ID:
903592
25
FDA Scrutiny of Promotion and Advertising Practices
13 Jul 2017 - 14 Jul 2017 • San Diego, United States
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
fda's advertising and promotion requirements, fda regulations for labelling, fda warning letter, fda legal authority, ftc, mass media, doj
Event listing ID:
903679
26
ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices
17 Jul 2017 - 18 Jul 2017 • Sydney, United States
Abstract:
Medical device manufacturing companies generate a copious number of documents when implementing a Quality and a Regulatory Management System. Various applications are available for purchase but at a high cost and unfortunately with ongoing maintenance license fees and the use of the service provider’s cloud systems which at times becomes questionable with current cybersecurity issues we all face. This session will take through a new paradigm in work practices for managing documentation without the need to continuously search and question obsolescence and relevancy. It will introduce the use of Microsoft Excel and hyperlinks to manage particular areas of document and project management. You will learn how to best manage your documents, remain compliant to ISO 13485 but most importantly eliminate one of the biggest time wasters when documents are saved by one person and retrieved by a different person in your organisation.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
ISO 13485 training, ISO 13485:2016, document management, risk assessment ISO 14971, risk analysis, quality and regulatory management documentation system
Event listing ID:
903644
27
A Comprehensive View of FDA Regulations for Medical Devices
20 Jul 2017 - 21 Jul 2017 • Cambridge, United States
Abstract:
Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820. Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.” Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
US medical device regulations, FDA medical device compliance best practices, FDA QSR, medical device reports (MDR), Unique Device Identification (UDI), Quality System Inspection Technique (QSIT), FDA inspections, medical device manufacturer
Event listing ID:
885021
28
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:
885042
29
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:
885052
30
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:
885062
31
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:
876580
32
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:
904176
Related subject(s):
33
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:
904142
Related subject(s):
34
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:
877328
35
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:
885127


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