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

Digital Marketing Training in San Mateo,CA-USA|Eduscil

Digital Marketing Training in San Mateo,CA-USA|Eduscil
Event on 2018-02-24 09:00:00
Digital Marketing Certified Associate Training The course covers core concepts of Digital Marketing such as Search Engine Optimization (SEO), Social Media Marketing, Pay-Per-Click (PPC), Website Conversion Rate Optimization, Web Analytics, Content Marketing, Mobile Marketing, Email Marketing, and Digital Marketing Strategy. The course will also help you master tools and platforms such as Google Analytics, AdWords, Twitter, YouTube, and Facebook. It includes Mimic Pro simulations to augment the concepts learned via virtual experience. Eduscil is conducting 4 days Digital Marketing Training in all major cities in United States. Register for this 4 day Digital Marketing training (Live Virtual classroom training course-Instructor Led), spread over one weekday and clear the Digital Marketing Exam from an expert trainer.  Features of Digital Marketing Training:  Online Interactive classroom training session spread over one weekends/weekdays Simulated Digital Marketing practice test Answers and explanations for all the practice questions Learn from an Digital Marketing expert Trainer Get 32 Contact Hours PDU certificate Examination fees included 100% Digital Marketing Exam pass back guarantee Case studies in the classroom training session Life time access to Digital Marketing recorded session Global Approvals and Accreditation Convenient classroom and online courses Courses conducted across the globe  For more information about our Digital Marketing training, please e-mail support@eduscil.com or Call Now! On +1 (713) 239 3167 | +1 (713) 239 3241 We also deliver onsite training for corporate groups. Contact us for group/corporate discount. 5.00% for 3-4 people 10.00% for 5-9 people 15.00% for 10 and above people Visit us at Digital Marketing Training to know more about our certification training courses in Program Management, ITIL, IT Service Management, Quality Management, Agile, Scrum, and related fields. We conduct Digital Marketing Training courses in Phoenix, Charlotte, Minneapolis, Boston, Chicago, Houston, Phoenix, Chicago, Washington, Los Angeles, Washington, Indianapolis, Dallas, San Diego, Baltimore and Richmond around USA… Please visit us at http://www.eduscil.com/ to know more about our professional certification training courses in India and across the globe. Please Contact Eduscil Solutions LLC: E-mail: support@eduscil.com or tony@eduscil.com Website: www.eduscil.com Call Us Now!: USA: +1 (713) 239 3167 | +1 (713) 239 3241

at San Mateo
1919 Alameda de las Pulgas
San Mateo, United States

Rokkkór Íslands órafmagnaðir

Rokkkór Íslands órafmagnaðir
Event on 2018-03-02 20:00:00
Rokkkór Íslands býður upp á órafmagnaða tónleika þar sem flutt verður góð blanda af þekktum rokklögum frá ýmsum áratugum. Með kórnum spila þeir Sigurgeir Sigmundsson, Ingólfur Magnússon og Þorbergur Ólafsson. Rokkstjóri er Matthías V. Baldursson (Matti sax)

at Salurinn
Kopavogur
Kópavogur, Iceland

Digital Marketing Training in West Jordan,UT-USA|Eduscil

Digital Marketing Training in West Jordan,UT-USA|Eduscil
Event on 2018-02-24 09:00:00
Digital Marketing Certified Associate Training The course covers core concepts of Digital Marketing such as Search Engine Optimization (SEO), Social Media Marketing, Pay-Per-Click (PPC), Website Conversion Rate Optimization, Web Analytics, Content Marketing, Mobile Marketing, Email Marketing, and Digital Marketing Strategy. The course will also help you master tools and platforms such as Google Analytics, AdWords, Twitter, YouTube, and Facebook. It includes Mimic Pro simulations to augment the concepts learned via virtual experience. Eduscil is conducting 4 days Digital Marketing Training in all major cities in United States. Register for this 4 day Digital Marketing training (Live Virtual classroom training course-Instructor Led), spread over one weekday and clear the Digital Marketing Exam from an expert trainer.  Features of Digital Marketing Training:  Online Interactive classroom training session spread over one weekends/weekdays Simulated Digital Marketing practice test Answers and explanations for all the practice questions Learn from an Digital Marketing expert Trainer Get 32 Contact Hours PDU certificate Examination fees included 100% Digital Marketing Exam pass back guarantee Case studies in the classroom training session Life time access to Digital Marketing recorded session Global Approvals and Accreditation Convenient classroom and online courses Courses conducted across the globe  For more information about our Digital Marketing training, please e-mail support@eduscil.com or Call Now! On +1 (713) 239 3167 | +1 (713) 239 3241 We also deliver onsite training for corporate groups. Contact us for group/corporate discount. 5.00% for 3-4 people 10.00% for 5-9 people 15.00% for 10 and above people Visit us at Digital Marketing Training to know more about our certification training courses in Program Management, ITIL, IT Service Management, Quality Management, Agile, Scrum, and related fields. We conduct Digital Marketing Training courses in Phoenix, Charlotte, Minneapolis, Boston, Chicago, Houston, Phoenix, Chicago, Washington, Los Angeles, Washington, Indianapolis, Dallas, San Diego, Baltimore and Richmond around USA… Please visit us at http://www.eduscil.com/ to know more about our professional certification training courses in India and across the globe. Please Contact Eduscil Solutions LLC: E-mail: support@eduscil.com or tony@eduscil.com Website: www.eduscil.com Call Us Now!: USA: +1 (713) 239 3167 | +1 (713) 239 3241

at West Jordan
9235 South Redwood Road
West Jordan, United States

Digital Marketing Training in Shreveport,LA-USA|Eduscil

Digital Marketing Training in Shreveport,LA-USA|Eduscil
Event on 2018-01-27 09:00:00
Digital Marketing Certified Associate Training The course covers core concepts of Digital Marketing such as Search Engine Optimization (SEO), Social Media Marketing, Pay-Per-Click (PPC), Website Conversion Rate Optimization, Web Analytics, Content Marketing, Mobile Marketing, Email Marketing, and Digital Marketing Strategy. The course will also help you master tools and platforms such as Google Analytics, AdWords, Twitter, YouTube, and Facebook. It includes Mimic Pro simulations to augment the concepts learned via virtual experience. Eduscil is conducting 4 days Digital Marketing Training in all major cities in United States. Register for this 4 day Digital Marketing training (Live Virtual classroom training course-Instructor Led), spread over one weekday and clear the Digital Marketing Exam from an expert trainer.  Features of Digital Marketing Training:  Online Interactive classroom training session spread over one weekends/weekdays Simulated Digital Marketing practice test Answers and explanations for all the practice questions Learn from an Digital Marketing expert Trainer Get 32 Contact Hours PDU certificate Examination fees included 100% Digital Marketing Exam pass back guarantee Case studies in the classroom training session Life time access to Digital Marketing recorded session Global Approvals and Accreditation Convenient classroom and online courses Courses conducted across the globe  For more information about our Digital Marketing training, please e-mail support@eduscil.com or Call Now! On +1 (713) 239 3167 | +1 (713) 239 3241 We also deliver onsite training for corporate groups. Contact us for group/corporate discount. 5.00% for 3-4 people 10.00% for 5-9 people 15.00% for 10 and above people Visit us at Digital Marketing Training to know more about our certification training courses in Program Management, ITIL, IT Service Management, Quality Management, Agile, Scrum, and related fields. We conduct Digital Marketing Training courses in Phoenix, Charlotte, Minneapolis, Boston, Chicago, Houston, Phoenix, Chicago, Washington, Los Angeles, Washington, Indianapolis, Dallas, San Diego, Baltimore and Richmond around USA… Please visit us at http://www.eduscil.com/ to know more about our professional certification training courses in India and across the globe. Please Contact Eduscil Solutions LLC: E-mail: support@eduscil.com or tony@eduscil.com Website: www.eduscil.com Call Us Now!: USA: +1 (713) 239 3167 | +1 (713) 239 3241

at Shreveport
504 Kings Highway
Shreveport, United States

Secret Funnel Marketing Strategy To Help You Make More Online Sales…

Secret Funnel Marketing Strategy To Help You Make More Online Sales…
Event on 2018-01-24 14:30:00
Secret Funnel Marketing Strategy To Help You Make More Online Sales…Even If You Have ZERO Online Marketing Experience [VIRTUAL EVENT]IMPORTANT NOTE: This is a Virtual Event. Registrants will be receiving an email with Web Class details. Do Online Marketing "Tricks" Still Work? It’s no secret. In the last few years making money online has gotten a LOT harder! Google slaps… Rising costs of traffic… Markets getting more sophisticated… In fact, some well known marketers have recently started to say that "online marketing as we know it is DEAD!" They say that a new breed of marketing has replaced it, and we all need to be Snapchatting and Instagramming all day without ever trying to sell anything… They claim that we can "guilt people into buying" by just giving… and giving… and giving some more… And the weird thing is, they’re right. You can’t just throw up a webpage, buy some adwords traffic and expect to be driving a Lamborghini within a couple months anymore… (In fact, it never really worked that way…) But at the same time… you don’t need to overcomplicate it and spend months building out a complex labyrinth that will just confuse your prospects. No. What you need now is the same thing you’ve always needed… A solid foundation. The right offer, presented to the right people, in the right delivery method will give you the ability to create cash “on demand” over and over again. And how can you find that offer, those people, and the right delivery method? Well, there are TWO paths. First, you can try to do it alone… "follow your passion” and just “do what feels right"… and in about 6 months, chances are pretty good you’ll be right where you started. The second path is smarter. Find someone else who has done what you want to do, and use their “framework” as your model. That way you’re building your business on a solid foundation, and you’ll be much more likely to succeed. Now you probably have lots of questions… "Where do I find someone to model?" "How do I know they’re making lots of money?" "Will this work for my business?" "What about the tech stuff?" And that’s why we want to invite you to this special web class training which will answer all those questions for you. We’ll show you a behind the scenes look of how to create winning offer, after offer, again and again. Who Should Attend: – Authors, Speakers, Consultants, Coaches, and Experts- CEO, Founder, Startup- Local Business Owners- Online Entrepreneurs, Affiliate Marketers- Retirees or Soon-To-Be Retirees- Office "Slaves" Trying To Escape Their J-O-B Important to note: This is NOT a "get-rich-quick" scheme or any MLM scheme. Please be advised that income and results shown are extraordinary and are not intended to serve as guarantees. In fact, as stipulated by law, we can not and do not make any guarantees about your ability to get results or earn any money with our ideas, information, tools or strategies. We don’t know you and, besides, your results in life are up to you. Agreed? We just want to help you by giving great content, direction and strategies that worked well for us and our students and that we believe can move you forward.

at Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Milwaukee, United States