Raleigh SEO Conference 2018

Raleigh SEO Conference 2018
Event on 2018-05-15 09:00:00
Can you believe the Raleigh SEO Meetup is hosting our third annual conference?! Our attendees learn about content marketing, search engine optimization for local businesses, and advanced agency strategies. One of the unique features of this conference is that speakers from across the country and right here in the Research Triangle provide actionable advice in a small group setting. Participants are delighted to have more interaction with marketing experts than at other conferences. It doesn't matter if you're new to SEO and looking to increase your skills or if you're an SEO agency owner, there's something here for everyone to learn. 2018 Raleigh SEO Meetup Conference This year we will have three tracks and 9 sessions covering the basics of online marketing and delving into the depths of agency management. We will also have keynotes from Jenny Halasz and Ashley Berman Hale! While the speaker lineup for 2018 is still being decided, past speakers have included: Phil Buckley Director of Technical SEO at Adapt, one of the Moz recommended companies in Raleigh JR Oakes Director of Strategy at ConsultWebs Patrick Stox SEO Specialist at IBM Karl Sakas Agency Consultant at Sakas & Company Will Hardison Agency Owner at FanBase Content Marketing & Social Media You know that content is king, but you're still trying to figure out how to create great content. More important than that, you need to know how to connect that content with the bottom line for your business – sales. These sessions will show you how to use written content, videos, photography, social media and more to connect with your audience online. You will come away with a wealth of ideas to drive engagement and sales in your business or for your clients. Local SEO & Voice Search While everyone needs to have an online presence today, not all businesses serve customers around the globe. Those that are trying to connect with people online that live in their neighborhood will benefit from a leason in local SEO. Do you know how to optimize the content on your website for personal digital assistants like Alexa? Are you closing deals after your business is found in search results? This is the track for you if your business, or your client's business, needs to stand out as a local provider in a global marketplace. Advanced Panel Discussions Do you count yourself among the most knowledgable marketing experts at any conference? Then this is the track for you. We've collected panels of agency owners and senior staff to answer your questions. This is your opportunity to geek out about online marketing and SEO with your peers. Learn what it takes to overcome the biggest challanges faced by marketing agencies around the world. The Latest Conference Details Visit RaleighSEOconference.com

at Nature Research Center Store
121 West Jones Street
Raleigh, United States

Preparing the Marketing Authorization Application in the EU, with a focus on the product information

Preparing the Marketing Authorization Application in the EU, with a focus on the product information
Event on 2018-04-18 09:00:00
Course "Preparing the Marketing Authorization Application in the EU, with a focus on the product information" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

In this seminar, we will look into all elements of the MAA dossier, in particular module 1, and within this module the Product Information. In addition, the various meetings with the Health Authorities in the centralized procedure will be discussed.
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
The PL reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easy-to-read format for patients.
The SmPC provides the basis of information for healthcare professionals to use a medicine safely, effectively and in the most appropriate manner. It is also a legal document, agreed between the Authorities and the relevant pharmaceutical company.
The format and content of the SmPC is laid down in EU/national legislation and regulatory guidance documents. Use of a medicine outside the conditions/ recommendations described in the SmPC falls under the responsibility of the healthcare professional.
It is important to note that the SmPC is not intended to provide general advice on the treatment of particular medical conditions. On the other hand, specific aspects of the treatment related to use of the medicine, or its effects may be mentioned. Similarly, general advice on administration procedures is not included, but any advice specific to the medicine concerned will be included, if appropriate.
The PL is drawn up in accordance with the SmPC and is subject to user-testing to ensure its ease of readability by patients/consumers. It plays an essential part in supporting the safe and effective use of a medicine by a patient. Consequently, it is important that a PL is provided each time a product is dispensed. Patients and care-givers should be encouraged to read the current version of the PL that accompanies their medicine(s) and to discuss any relevant concerns with a healthcare professional involved in their care.
Pre-submission meetings with the EMA and Rapporteurs are a vital element in the preparation of the MAA filing, and knowledge of the how to conduct these is vital for a successful outcome

Why should you attend:

This seminar is specifically designed for personnel that will have to prepare a Marketing Authorisation Application in the EU. It is important to do this correctly, as otherwise the application may be rejected at validation (at the time of submission) or there may be delays later in the process
Product Information is a key part of the marketing authorisation of all medicines authorised in the European Union
The product information is comprised of the Summary of Product Characteristics (SmPC) and the PL. These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine, to reflect the current state of knowledge of the medicine and the risks associated with its use. The SmPC is mainly intended for use by healthcare professionals
SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients.
The labelling and package leaflet are important tools to achieve correct use of the medicinal product. Marketing Authorisation Holders (MAHs) are required to ensure that current versions of the labelling and package leaflet are used when medicines are supplied to pharmacies.

Areas Covered in the Session:

• SmPC
• Package Leaflet
• Labelling
• Readability testing
• How to conduct presubmission meetings with the EMA and Rapporteurs

Who will benefit:
• Regulatory Affairs personnel involved in Development of medicinal products

Agenda:
Day 1 Schedule
Lecture 1:
Introductions
1.0 Cover Letter
1.1 Comprehensive Table of Contents
1.2 Application Form
1.3 Product Information
1.4 Information about the Experts
1.5 Specific Requirements for Different Types of Applications
1.6 Environmental Risk Assessment
1.7 Orphan Market Exclusivity
1.8.1 Pharmacovigilance system, where appropriate
1.8.2 Risk-Management System
1.9 Information relating to clinical trials
1.10 Information relating to Paediatrics
Lecture 2:
In-dept review of requirement for product information

Day 2 Schedule

Lecture 1:
In dept review of requirement for product information (continued)
Lecture 2:
Pre-submission meetings with EMA and Rapporteurs

Speaker:
Adriaan Fruijtier
Regulatory Affairs Consultant, CATS Consultants GmbH

Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.
He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997.
Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.

Location: Zurich, Switzerland Date : April 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Price:

Register now and save 0. (Early Bird)
Price: ,695.00 (Seminar Fee for One Delegate)
Until March 10, Early Bird Price: ,695.00 From March 11 to April 16, Regular Price: ,895.00
Register for 5 attendees Price: ,085.00 ,475.00 You Save: ,390.00 (40%)*
Register for 10 attendees Price: ,322.00 ,950.00 You Save: ,628.00 (45%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901315SEMINAR?eventful-April-2018-SEO

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at Hilton Zurich Airport
Zurich, Switzerland
, Switzerland

FDA Audit Checklist Clinical Trials Seminar 2018

FDA Audit Checklist Clinical Trials Seminar 2018
Event on 2018-04-26 09:00:00
Course "Managing Your FDA Inspection: Before, During and After" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. The course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries, they just seem like it. Why you should attend: "Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. You think, "Why is FDA here? Are we in trouble?" Are you prepared to talk about the trouble you know you have with FDA regulations or is your plan of action to cross your fingers. We all know that a bad FDA inspection has immediate and long-term consequences. The cost of fixing your problems, the bad public relations, upset customers and future business plans can be set into a downward spiral. If you do not understand what FDA is doing or thinking, how can you expect to deal successfully with FDA? If you don't know how to anticipate an investigator's actions or follow their train of thought, you will not be able to mitigate the effect of inspectional findings. "Is FDA going to send us a Warning Letter?" You can make a reasonable prediction if you understand your inspectional results and how FDA will "grade" it. The tools are available. Areas Covered in the Session FDA legal authorityTypes of inspectionsFDA investigator trainingFDA's written procedures, policy and operations guideIndustry inspection protocolWhat to do and not do during an inspectionForm FDA 483 responseWarning Letter responseEnforcement Who Will Benefit: Regulatory AffairsQuality AssuranceManufacturing Agenda: Day 1 Schedule Lecture 1: FDA Inspection authority FDA Inspection authorityInspectional refusal prohibition Lecture 2: Types of Inspections: purpose, scope and scrutiny Comprehensive GMPAbbreviated GMPDistrict or Center DirectedRegulatory Follow-upSurveillanceLimitedFor Cause Lecture 3: Impact on you during and after inspection How to interact with the FDA investigatorWhat not to say and doYour protocolMismanagement of the inspection Lecture 4: FDA Investigator Training – This is what they are thinking On the job training and supervisionTechnical, classroom and mock inspectionsEvidence development to tell the storyPhysical and documentary samples of your violationsWriting reports, inspectional observations and sample documentationPhysical threats and assault Lecture 5: Investigations Operations Manual Procedures and technical guidance. FDA's rules for themselvesFDA organization chart "in the field." Who is watching you? Compliance Programs Section III – the inspection / specific issuesSection V – the regulatory response / risk assessment Lecture 6: Investigations Operations Manual (continued) Writing inspectional observations (Form FDA 483)Writing establishment inspection reportsEvidence documentation and custody Mock "Limited" inspection Day 2 Schedule Lecture 1: FDA Form 483 – List of objectionable conditions, aka list of observations PurposeFormat / organizationManaging 483 observations during the inspectionResponding to 483 observations during "discussion with management" What it meansHow to manage the discussionHow to challenge a 483 observationWhat to say and not say Lecture 2: Your written response to a 483 Understanding the 483 – using an FDA issued 483Time deadlinesStrategy for corrections and corrective actionEvidence of corrections and corrective actionEmpty promises Lecture 3: FDA Warning Letter – advisory of possible legal action FDA Warning Letter proceduresResponding to a Warning Letter – in 15 working days. Group Hypothetical Warning Letter Response – in 10 minutes Lecture 4: FDA Enforcement Actions Judicial SeizureInjunctionProsecutionMonetary penalties Administrative Import / ExportGovernment contractsOther government agency advisoriesFinesPremarket holds Speaker Casper Uldriks ex-FDA Expert and former Associate Center Director of CDRH Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Location: Seattle, WA Date: April 26th & 27th, 2018 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA Price: Register now and save 0. (Early Bird) Price: ,295.00 (Seminar Fee for One Delegate) Until March 10, Early Bird Price: ,295.00 From March 11 to April 24, Regular Price: ,495.00 Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)* Register for 10 attendees Price: ,122.00 ,950.00 You Save: ,828.00 (45%)* Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel Early Bird – Seminar Fee for One Delegate – 95.00 Regular Price – 95.00 Register for 5 attendees – 85.00 Register for 10 attendees – 22.00

at Courtyard Seattle Sea-Tac Area
16038 West Valley Highway Tukwila Washington 98188 USA
Seattle, United States