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Combination Products 2017

Start Date:
Thursday, 28 September, 2017
End Date:
Friday, 29 September, 2017 6:00pm
Neurology, Gastroenterology, Cardiology, Endocrinology, Infectious Disease, Gynecology, Emergency Medicine, Hematology

Course "Combination Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This seminar provides Professionals working in this area withA thorough understanding of the complexities involvedAll the relevant regulations and guidelinesReal life examples of how to register and maintain various types of combination productsInterfaces: Change Management and LCMCompliant safety reporting for combination productsDocumentation requirements and interfacing Why you should attend : Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.

Areas Covered in the Session: Documentation requirements and interfacingDocumentation requirements for combination products EUDocumentation requirements for combination products USInterfacing, development, quality, regulatoryManaging third parties and document control. Who Will Benefit: Regulatory AffairsMedical OfficersClinical Trial Managers Agenda: Day 1 Schedule Lecture 1:A high level overview to Combination ProductsIncluding an interactive group session reviewing individual expectationsLecture 2:Introduction to Drug/Device RegulationsDuring this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products.

Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities. Regulatory Requirements for: US and EULecture 3:CE Marking, 510 K and PMAs general OverviewUS and EULife Cycle ManagementInterfaces: Change ManagementCTA applicationsAnnual reportingLecture 4:CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercisesWrap up of day 1 & Q&A's Day 2 Schedule Lecture 1:Overview Combination product Regulation and CTD dossier requirments: EU and US (A comparative review)Lecture 2:Clarifying the regulatory requirements of combination products and addressing life-cycle managementExamining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral productsAnnual reportsCase studiesLecture 3:CASE STUDY 2Lecture 4:Compliant safety reporting for combination productsTaking into account your product's combined components when addressing adverse event reportingDocumentation requirements and interfacingDocumentation requirements for combination products EUDocumentation requirements for combination products USInterfacing, development, quality, regulatoryManaging third parties and document control.CASE STUDY 3Wrap up of day 2Final Q&A & Summary of 'working smart' with Combination Products SpeakerSalma MichorPhD, MSc, MBA, CMgr, RAC Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive.

Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

Location: Boston, MA Date: September 28th & 29th, 2017 and Time: 9:00 AM to 5:00 PMVenue: Embassy Suites Boston Logan Airport 207 Porter Street Boston, MA 02128 Price: Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until August 10, Early Bird Price: $1,295.00 From August 11 to September 28, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt 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- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


Embassy Suites Boston Logan Airport 207 Porter Street Boston,

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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