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

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

at Hilton Zurich Airport
Zurich, Switzerland
, Switzerland

Verification vs. Validation – Product Process Software and QMS 2018

Verification vs. Validation – Product Process Software and QMS 2018
Event on 2018-01-22 09:00:00
Course "Verification vs. Validation – Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: Understand Verification and Validation, differences and how they work together;Discuss recent regulatory expectations;Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;Determine key "milestones" and "tasks" in a project;Locate and document key subject "inputs";Compile "generic" Master and Individual Validation Plans;Learn the key element of a Product V&V File/Protocol;Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;Get a grasp of basic Test Case construction;Understand sample sizes and their justification;Learn the key elements of Software V&V expected by the FDA and how to document;Deal with hardware and software vendors, sales and marketingConsider a field-tested software V&V documentation "model";See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11. Who will benefit: This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation. The employees who will benefit include: Senior and middle management and staffRegulatory AffairsQuality Assurance or Quality Control ProfessionalsQA/QCIT/ISR&DProduction ManagementManufacturing EngineersProcess EngineersSoftware EngineersProject ManagersHardware and software vendors, sales and marketingAny professional tasked with V&V responsibilities Agenda: Day 1 Schedule Lecture 1: Master Validation Planning and the Master Validation Plan(s) Lecture 2: Product, Process / Equipment Hardware V&V Lecture 3: Product / Device V&V Lecture 4: Software V&V Lecture 5: Quality Management System / 21 CFR Part 11 V&V Lecture 6: Summary of morning discussion Lecture 7: Group activity on the MVPs Lecture 8: Review of group activity and Q&A Day 2 Schedule Lecture 1: Software V&V documentation "model" Lecture 2: Software V&V protocols – "black box", "white box" Lecture 3: Electronic Records and Electronic Signatures (Part 11) Lecture 4: Summary of morning discussion Lecture 5: Group activity on 1) hardware / equipment, and 2) software V&V protocols Lecture 6: Review of group activity and Q&A Lecture 7: Course summary discussion Lecture 8: Summary of morning discussion Lecture 9: Group activity on the MVPs Lecture 10: Review of group activity and Q&A Speaker John E Lincoln Consultant, Medical device and Regulatory affairs, John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt. Location: St. George UT Date: January 22nd & 23rd, 2018 and Time: 9:00 AM to 6:00 PM Venue: Hilton Garden Inn St. George 1731 South Convention Center Drive, Saint George, Utah, 84790, USA Price: Price: ,295.00 (Seminar Fee for One Delegate) Register now and save 0. (Early Bird) Until January 01, Early Bird Price: ,295.00 From December 31 to January 20, 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 – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901450SEMINAR?ticketleap-January-2018-SEO 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 Seminar Fee for One Delegate – 95.00

at The Hilton Garden Inn
1731S.ConventionCenterDrive
Saint George, United States

Bill Guthrie Interviews Successful Entrepreneurs and Marketers, inspired by Tim Ferris, John Lee Dumas, Pat Flynn, Seth Godin, Michael Hyatt, about Online Business, Social Media, Software, Product Creation, Building a Business and Becoming an Entrepreneu – PeakMarketer | Daily Interviews with Today’s Top Marketers and Entrepreneurs


Bill Guthrie Interviews Successful Entrepreneurs and Marketers, inspired by Tim Ferris, John Lee Dumas, Pat Flynn, Seth Godin, Michael Hyatt, about Online Business, Social Media, Software, Product Creation, Building a Business and Becoming an Entrepreneu – PeakMarketer | Daily Interviews with Today’s Top Marketers and Entrepreneurs
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Marketing Product Demos & Social

Marketing Product Demos & Social
Event on 2015-10-15 18:00:00
The Marketers Unbound marketing product demos event series allows Toronto-based marketing leaders to connect with each other and learn about products that would help their brands win.   We'll have 3 marketing product demos, followed by a q&a session with the speakers:  1. ScribbleLive content marketing software, presented by account executive Joe Ward 2. Environics Analytics marketing analytics suite, presented by director of product management Teresa Sinopoli 3. GShift SEO and content optimization software, presented by to be announced  Q&A session with the speakers moderated by Francois Mathieu, marketing product manager at Uberflip. Format: 6:00 to 6:15pm registrations and social time (snacks and coffee provided) 6:15 to 6:30pm introductions (by the organizer + every attendee gets to introduce himself/herself) 6:30 to 7:10pm three product demos (each speaker will have 10 minutes for his/her presentation) 7:10 to 7:35pm question & answer session with the three speakers 7:35 to 8:00pm social time (snacks and coffee provided)   Our hashtag is #MarketersUnbound  ======================================== Organized by:  Marketers Unbound is a regular gathering of marketing leaders who help forward-looking brands who engage in presentations and panel discussions addressing today's challenging marketing environment.  Canadian Association of Marketing Professionals is a non-profit organization focused on uniting all marketers across Canada. Our mission is to create an inclusion-based network for all marketers to join, network, further their professional development, and deepen their connection to their profession.  ======================================== Venue partner: Uberflip: your content management system. Streamline content management, accelerate lead generation, and fuel marketing automation with Uberflip. ======================================== Want to present at or become a partner of the Marketers Unbound event series? Get in touch with us: alex@alexrascanu.com.

at Uberflip
135 Liberty St
Toronto, Canada

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ST. LOUIS, Oct. 5, 2015 /PRNewswire/ — Equifax Workforce Solutions, a leader in human resource, analytics and verification services, and a business unit of Equifax Inc. (NYSE:EFX), today announced I-9 Anywhere, a cutting-edge software package enabling …
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IOWA CITY, Iowa, Oct. 5, 2015 /PRNewswire/ — NASCAR investor Anthony Marlowe has officially announced that he has repurchased TMone – the company he sold in 2013 – in its entirety. As of October 1, TMone has been renamed Mass Markets. The new …
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Shark Tank-Esque Product Launchers CEO Named Top 40 Under 40


Haverstraw, NY (PRWEB) June 12, 2015

Linda Parry, CEO, Product Launchers, has been named one of Westchester County Business Councils 40 Under 40 Rising Stars. The 40 Under 40 program recognizes individuals in Westchester, NY who surpass expectations, raise the bar and set new standards for success. Hundreds of nominations were submitted, only the top 40 were chosen by the Council. Parry and other winners were honored during an award ceremony last night at 800 Westchester Avenue in Rye Brook, NY.

Linda Parry, 33, is founder and CEO of Product Launchers, a marketing, sales and distribution powerhouse. “We’re a young and fast-growing company that works tirelessly to generate results. It was an honor to achieve such a distinction.”

Product Launchers, a New York-based Shark Tank alternative, works with inventors and companies to bring emerging products to market via retail partnerships, trade shows, traditional and digital marketing, social media and public relations. In addition to generating sales, the company serves as a distributor by warehousing/fulfilling orders and leveraging their existing vendor accounts.

We are inventors ourselves who have successfully orchestrated our own new product launches. We apply these proven practices to our clients inventions,” says Parry.

Product Launchers’ successes cover a wide gamut of product segments, from gourmet seafood pies and childrens step stools to womens accessories and outdoor tossing games. The company has established relationships with Walmart, Bed Bath and Beyond, Toys R Us, Whole Foods Market, Sears, Kmart, TJ Maxx, Home Depot, Tractor Supply Company and more.

Prior to Product Launchers, Parry was Senior Vice President of a global marketing firm. She possesses her Bachelor’s in Marketing/Management from Siena College, Master’s in Advertising from S.I. Newhouse School of Public Communication and Juris Doctor from Syracuse University College of Law.

For more information, please visit http://www.productlaunchers.co, email info(at)productlaunchers(dot)co or call 914-712-8824.







Online Company B&B Internet Marketing LLC Introduces New Health Product

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CALGARY, Canada, June 15, 2015 /PRNewswire/ — Calgary web-based company, B&B Internet Marketing LLC, today unveiled its new health product supply store at www.UnlimitedHealthyChoices.com. The new online store offers a select array of …
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Without links, the internet simply would not function the way it does today. If you're marketing your business online, you must account for links. Not only are links enormously important, but link acquisition itself actually fits in quite naturally …
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Why PR gurus always print the myth
From one man and his Filofax to a global phenomenon that shapes our culture, public relations is laid bare at a new show at the V&A. For 40 years Alan Edwards has guided the brightest lights in rock, pop and celebrity and his vast collection of …
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Ballantines Public Relations Wins Coveted Marriott International Lifestyle
LOS ANGELES, May 19, 2015 /PRNewswire/ — Ballantines Public Relations (BPR), the award-winning global lifestyle PR agency, is thrilled to announce that Marriott International Lifestyle Brands has chosen the company as their official international …
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Control Solutions adds Mosquito Mist Ultra to its already diverse vector control product line


Pasadena, Texas (PRWEB) May 24, 2015

Control Solutions adds Mosquito Mist Ultra to its already diverse vector control product line. Mosquito Mist Ultra contains 20.6% permethrin and 20.6% piperonyl butoxide (PBO), which allows the product to maximize its effectiveness against mosquito populations including species that transmit West Nile Virus. Mosquito Mist Ultra has the versatility to be mixed with both water or oil, and is designed for ultra low-volume (ULV) and thermal fogging applications.

For more information on Mosquito Mist Ultra and CSI’s vector control line, visit their website at http://www.controlsolutionsinc.com.

About Control Solutions Inc. (CSI)

Control Solutions began as a family owned business in 1958 and is built on to the commitment of serving the professional pest control and retail markets. CSI has added product lines for the Industrial, Lawn and Garden, Animal Health and Biocide markets, and is working with over 80 distributors serving those markets. Control Solutions maintains relationships with chemical manufacturers worldwide and provides a ready supply of products in distribution warehouses across the U.S. The partnership with ADAMA (formerly Makhteshim-Agan Industries) multiplies Control Solutions agility in continuously adding new products to meet the needs of professionals and homeowners. “The one constant since the beginning in 1958 is our mission focus: to seek out and distribute effective and economical solutions for our customers,” stated Mark Boyd, President and founder of CSI.

About ADAMA Agricultural Solutions

ADAMA Agricultural Solutions Ltd. is a leading global manufacturer and distributor worldwide of crop protection solutions. The Company supplies efficient solutions to farmers across the full farming value-chain, including crop-protection, novel agricultural technologies, and complementary non-crop businesses. In 2012, the Company’s revenues were over $ 2.83 billion, and it is ranked seventh in the world in the overall agrochemicals industry. The Company is characterized by its heritage of innovation, farmer-centric approach to product development, and observance of strict standards of environmental protection and quality control.

For more information about ADAMA, visit http://www.adama.com.