Events

Conferences

August 8-10, 2018

FDAnews - ICH E6 GCP INTERACTIVE WORKSHOPS
Waltham, MA

The clinical trials world is going back to school. New ICH E6 (R2) guidelines require trial sponsors to institute risk assessment at both the system and clinical trial levels and require drug and biologics makers to qualify vendors.

You can get all the training you need to meet these challenges with three days of hands-on workshops aimed at helping you understand and comply with new ICH E6 (R2) requirements. Teaming up with Technical Resources International Inc., we’ve created a pair of workshops that meet the needs of everyone along the clinical trials spectrum, from trial sponsors to trial operators and overseers. These workshops are aimed at every sector of the clinical trials world—drug and biologics makers; trial sponsors, trial sites and CROs; academic medical centers and IRBs—and the individuals who make trials happen:

  • QA/QC managers and staff
  • RA managers and staff
  • Compliance auditors
  • Manufacturing managers
  • Project managers
  • Senior managers
  • Supply chain and logistics managers

For details and registration, Click Here

September 10-12, 2018

MASTERING EU MEDICAL DEVICE REGULATION
Philadelphia, PA

Devicemakers face an array of tough new rules as the EU phases in the new Medical Device Directive (MDR) — rules that will change how you do business everywhere in the world.

  • Your entire product portfolio will need re-approval
  • Standards such as the ISO 13485:2016, changed once already, will change again to align with the new MDR
  • Turnaround time for incident reporting will drop from 30 to only 15 days

This barely scratches the surface. The MDR, which replaces the existing Medical Device Directive (MDD), is 175 pages (vs. 60) of new provisions ... changes to existing ones ... inclusions ... and exclusions. And confusion abounds: Rules for accrediting Notified Bodies (NB) aren’t even final yet, for example.

You may think you have lots of time to comply but you don’t: Fewer than two years. Here’s what to do NOW. Mark your calendar for an intense hands-on training session in Boston, Tuesday-Thursday, Sept. 10-12. Over the course of two days understanding and implementing the new MDR ­— plus a third add-on day focusing on post-market activities — you’ll discover:

  • The new MDR classification system: How to apply it
  • Conformity assessment paths: How they apply to specific devices
  • Annex I requirements: How to document compliance
  • Technical documentation requirements in Annex I and Annex II
  • Unique Device Identification: The EU approach
  • Economic operators and their relationship to you
  • Notified Body: What it is, what it does
  • And MUCH more!
  • Many workshop exercises will be tailored to your specific products. You’ll receive detailed checklists to help classify devices, apply Annex I requirements and conduct internal quality audits, as well as:
    • A map from the MDD Annex I to the MDR Annex I
    • A workbook of device attributes used for UDI implementation

    For details and registration, Click Here

  • October 23-25, 2018

    FDA Inspections Summit - 13th Annual
    Bethesda, MD

    Mark your calendar for the 13th Annual FDA Inspections Summit taking place Oct. 23-25, 2018 in Bethesda, MD. The Summit is THE place to hear from current and former FDA officials and top industry experts. The program is coming together nicely and will include specialized tracks for:

    • Medical Devices
    • Pharmaceuticals
    • Clinical Trials

    Testimonials from Past Attendees:

    • “Great discussion and knowledgeable panel. I enjoyed having the FDA give examples in their own words…” Dan Lewis, Site Quality Leader, P&G
    • “The panels were great. Very informative and great discussions.” Nancy Carranza, Vice President, Operations, GSMS, Inc.

    For details and registration, Click Here

    Training Programs

    Phlebotomy Training in 2 days!


    Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

    www.phleb.com/privategroups

    Webinars

    June 21, 2018

    A CenterWatch/FDAnews Webinar

    The Real Impact of Common Rule in 2018: Understanding Nuances, Facilitating Compliance & Implementing Best Practices

    1:30 p.m. - 3:00 p.m. EDT

    The first revisions to the Common Rule in more than a decade have thrown the clinical trials industry into a seemingly perpetual spin cycle. This webinar will enable you to fully understand the key changes to the Common Rule and how they dramatically impact IRBs and virtually every entity engaged in clinical research. Save this date — March 27, 2018 — to hear one of the leading authorities on the Common Rule rule explain:

    • Changes to Informed Consent, which add new requirements for consent documents and new guidance for investigators in the consent process.
    • Changes to Broad Consent, which now allows, but does not require, researchers to request broad consent from subjects for secondary research involving identifiable private information and identifiable biospecimens.
    • Implementation of Limited IRB Review, which introduces this new concept in connection with exempt research, expedited review and the criteria for IRB approval of research.
    • Exemptions, including provisions that modify existing categories of exempt research, add new exemptions for certain low-risk studies and provide additional carve-outs for activities not classified as research.
    • Updates to SOPs, which result in institutions and IRBs having to update their standard operating procedures, including the definitions of “research” and “human subjects.”
    • And much more!

    Make sure you continue to receive grant funding from federal agencies and departments that have adopted the Common Rule. And avoid allegations of noncompliance or incident reporting to the OHRP.

    Your presenter, Carrie Hanger, Esq., an expert on clinical trial regulation and a partner in the law firm of Nelson Mullins Riley & Scarborough, will provide the information you need to obtain grants and avert noncompliance.

    As you’ll hear from Ms. Hanger, the implementation date for compliance with the new regulations and guidance is set to kick in before you know it, but even that date is in flux (all the more reason to attend the webinar).

    Do not get stuck in this legal quicksand. Take advantage of this timely presentation to learn the nuances of the revisions and the tips you can put into place to achieve complete compliance. Sign up now.

    Meet Your Presenter

    Carrie Hanger, Esq., is a partner at Nelson Mullins Riley & Scarborough specializing in the regulatory compliance of healthcare providers and clinical and preclinical decisionmakers and researchers in the U.S. With more than a decade of direct experience representing and counseling clients, Hanger provides solutions for issues relating to enrollment and reimbursement, licensure and certification, regulatory and corporate compliance, risk management and business disputes. She regularly analyzes issues related to clinical and preclinical research and drafts and negotiates clinical research-related documents, such as clinical trial agreements and confidentiality agreements. Carrie has spoken at numerous CLEs and seminars for healthcare providers concerning reimbursement and compliance issues related to clinical research.

    Who Will Benefit

    This session is appropriate for organizations subject to the regulatory implementation of the Common Rule, including CPSC regulation, specifically individuals holding job titles including:

    • Regulatory and compliance specialist
    • IRB member or staffer
    • Principal investigator
    • Study coordinator
    • Clinical researcher or associate
    • Clinical recruiter
    • Risk manager
    • General or outside counsel
    • Institutional official
    • Medical affairs director

    REGISTER NOW

    July 11, 2018

    A CenterWatch/FDAnews Webinar

    Preparing for the MDSAP Audit Process: A Case Study from the Manufacturer’s Perspective

    1:30 p.m. - 3:00 p.m. EDT

    Devicemakers that export into Canada, Japan, Australia and Brazil face important changes to the audit and inspection process as the new Medical Device Single Audit Program (MSDAP) goes into effect.

    The deadline is looming: Canada imposes the new requirements next Jan. 1.

    The changes differ in important ways from what you’re used to. Now is the time to get a drop on them.

    Mark your calendar for Wednesday, July 11, when consultant Connie Hoy takes you through the changes — what’s the same, what’s different, how you’ll have to alter your thinking. In 90 lightning minutes, she’ll touch on such key factors as:

    • Using the Companion Document to most successfully prepare for the MDSAP audit
    • Quality system: Insuring that yours completely covers specific country requirements
    • Registration review details: Specifics to expect in this portion of the audit
    • Differences in emphasis: Unfamiliar questions the MDSAP auditor is likely to ask
    • Audit procedures: How the MDSAP audit is conducted and how it differs from FDA inspections and ISO audits
    • “Grading system for nonconforming”: What it really means
    • And much more!
    • MSDAP audits will be a reality before you know it — less than 6 months. Don’t get caught short. Start figuring things out now with this webinar.

    Who Will Benefit

    Devicemakers that export to Canada, Japan, Australia and Brazil will benefit from this presentation in general, as will exporters of high-risk devices; and exporters of combination products to Australia will benefit specifically. Job titles include but are not limited to:

    • Regulatory/compliance
    • Quality assurance
    • Manufacturing/GMP/cGMP
    • Supply chain executives
    • Auditors
    • Legal counsel

    REGISTER NOW

    July 19, 2018

    A CenterWatch/FDAnews Webinar

    European Medical Device Regulations (EU MDR): Strategic Planning for the Coming Critical Changes

    11:00 a.m. - 12:30 p.m. EDT

    Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations.

    The number of rules will increase from 18 to 22, dramatically impacting what quality and regulatory specialists do every day. Changes in classification rules will require manufacturers to confirm and update documentation to reflect the changes. And this just scratches the surface.

    Now, you can be prepared for all the changes with a new webinar/book combo offer from FDAnews. The webinar will provide clear explanations of the changes and gives you the chance to ask questions of an expert. The book supplies you with instructions and checklists to ensure you have done everything to ensure compliance! You can rest easy knowing that you understand all the changes, and have the documents you need to get your organization ready!

    James Pink has spent recent years immersing himself in the details and ramifications of this groundbreaking change. A device expert with extensive EU experience, Mr. Pink now brings his expertise to you.

    Mark your calendar for July 15 and 90 minutes of total immersion into the forthcoming changes. You’ll discover:

    • How the aforementioned rules increase, from 18 to 22, could affect your job
    • Documentation confirmation and updating: Specific changes you’ll be required to make
    • New separate software rules and what they say
    • Stricter requirements for implantable devices: The impact on quality and compliance
    • The consequences of delay: Sanctions you could face, markets you could lose
    • And much more!

    PLUS, you’ll receive a copy of our bestselling book: EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing. The report provides:

    • Definitions of key terms in the EU MDR
    • Knowing where to find specific requirements in the 150+ page regulation
    • Checklists that walk you through every aspect of manufacturing, safety and performance requirements
    • A training tool for employees new to the regulations
    • EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements is the tool that collects all the requirements, explains them and itemized them in an easy-to-use form to ensure compliance.

    The compliance deadline may be in 2020, but don’t kid yourself. The time to start preparing is right now. This webinar/book combo is the perfect start. Sign up today.

    REGISTER NOW