�ݺ�ߣshows by User: FreyrInc

�ݺ�ߣshows by User: FreyrInc / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: FreyrInc / Mon, 15 Apr 2019 08:13:36 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: FreyrInc Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance /slideshow/clinical-evaluation-report-cer-decode-the-stepwise-approach-for-compliance/140845807 freyrcerwebinarpromotion-190415081336
We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on 11 December 2018. But with your keen interest on CER Authoring as per updated MED DEV 2.7/1 Rev 4, we assume you would like to go through the session. In that regard, let us share with you a FREE copy of webinar recording. In brief during the session, we discussed about decoding the step-wise approach for compliant Clinical Evaluation Report, inclusive of: 1. CER- Industry Reception in last 2 years 2.Clinical Data, Evaluation and Evidence - Overview 3. PMS Data – Key Input for CER 4. Clinical Evaluation - Key component for Clinical Evidence 5.Key High Lights of MEDDEV 2.7/1 REV 4 6. Clinical Evaluation Report- Key Characteristics 7.Focus points for a “compliant CER” 8.Stage wise approach for CER Authoring 9.Key Impact Elements for CER Projects 10. 4Q – Requirement consolidation 12.Accelerators/ Enablers in CER Projects ]]>
We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on 11 December 2018. But with your keen interest on CER Authoring as per updated MED DEV 2.7/1 Rev 4, we assume you would like to go through the session. In that regard, let us share with you a FREE copy of webinar recording. In brief during the session, we discussed about decoding the step-wise approach for compliant Clinical Evaluation Report, inclusive of: 1. CER- Industry Reception in last 2 years 2.Clinical Data, Evaluation and Evidence - Overview 3. PMS Data – Key Input for CER 4. Clinical Evaluation - Key component for Clinical Evidence 5.Key High Lights of MEDDEV 2.7/1 REV 4 6. Clinical Evaluation Report- Key Characteristics 7.Focus points for a “compliant CER” 8.Stage wise approach for CER Authoring 9.Key Impact Elements for CER Projects 10. 4Q – Requirement consolidation 12.Accelerators/ Enablers in CER Projects ]]> Mon, 15 Apr 2019 08:13:36 GMT /slideshow/clinical-evaluation-report-cer-decode-the-stepwise-approach-for-compliance/140845807 FreyrInc@slideshare.net(FreyrInc) Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance FreyrInc We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on 11 December 2018. But with your keen interest on CER Authoring as per updated MED DEV 2.7/1 Rev 4, we assume you would like to go through the session. In that regard, let us share with you a FREE copy of webinar recording. In brief during the session, we discussed about decoding the step-wise approach for compliant Clinical Evaluation Report, inclusive of: 1. CER- Industry Reception in last 2 years 2.Clinical Data, Evaluation and Evidence - Overview 3. PMS Data – Key Input for CER 4. Clinical Evaluation - Key component for Clinical Evidence 5.Key High Lights of MEDDEV 2.7/1 REV 4 6. Clinical Evaluation Report- Key Characteristics 7.Focus points for a “compliant CER” 8.Stage wise approach for CER Authoring 9.Key Impact Elements for CER Projects 10. 4Q – Requirement consolidation 12.Accelerators/ Enablers in CER Projects <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/freyrcerwebinarpromotion-190415081336-thumbnail.jpg?width=120&height=120&fit=bounds" /> We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on 11 December 2018. But with your keen interest on CER Authoring as per updated MED DEV 2.7/1 Rev 4, we assume you would like to go through the session. In that regard, let us share with you a FREE copy of webinar recording. In brief during the session, we discussed about decoding the step-wise approach for compliant Clinical Evaluation Report, inclusive of: 1. CER- Industry Reception in last 2 years 2.Clinical Data, Evaluation and Evidence - Overview 3. PMS Data – Key Input for CER 4. Clinical Evaluation - Key component for Clinical Evidence 5.Key High Lights of MEDDEV 2.7/1 REV 4 6. Clinical Evaluation Report- Key Characteristics 7.Focus points for a “compliant CER” 8.Stage wise approach for CER Authoring 9.Key Impact Elements for CER Projects 10. 4Q – Requirement consolidation 12.Accelerators/ Enablers in CER Projects

Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance from Freyr Solutions

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0 REGULATORY LABELING AND THE INDUSTRY CHALLENGES /slideshow/regulatory-labeling-and-the-industry-challenges/75882984 regulatorylabelingchallenges-170511103045
To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle. In that regard, before even searching for a right labeling solution..... ]]>
To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle. In that regard, before even searching for a right labeling solution..... ]]> Thu, 11 May 2017 10:30:45 GMT /slideshow/regulatory-labeling-and-the-industry-challenges/75882984 FreyrInc@slideshare.net(FreyrInc) REGULATORY LABELING AND THE INDUSTRY CHALLENGES FreyrInc To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle. In that regard, before even searching for a right labeling solution..... <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/regulatorylabelingchallenges-170511103045-thumbnail.jpg?width=120&height=120&fit=bounds" /> To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle. In that regard, before even searching for a right labeling solution.....

REGULATORY LABELING AND THE INDUSTRY CHALLENGES from Freyr Solutions

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0 Regulatory Software /slideshow/regulatory-software/74973877 regulatorysoftwareforslideshare-170413092213
To keep pace with Health Authority mandates and requirements, there is a dire need for Pharma/Biotech/Cosmetic/Medical Device manufacturers or organizations to automate their processes. There comes the requirement for Regulatory software which should be flexible, secured and cloud-hosted aligning with region specific submission formats and data requirements. As a specialist, Regulatory software provider Freyr offers proven tools for Publishing and submission, labeling, IDMP, Identity, Intelligence, document management and trial master files. Gain more knowledge on specialized Regulatory tools. ]]>
To keep pace with Health Authority mandates and requirements, there is a dire need for Pharma/Biotech/Cosmetic/Medical Device manufacturers or organizations to automate their processes. There comes the requirement for Regulatory software which should be flexible, secured and cloud-hosted aligning with region specific submission formats and data requirements. As a specialist, Regulatory software provider Freyr offers proven tools for Publishing and submission, labeling, IDMP, Identity, Intelligence, document management and trial master files. Gain more knowledge on specialized Regulatory tools. ]]> Thu, 13 Apr 2017 09:22:12 GMT /slideshow/regulatory-software/74973877 FreyrInc@slideshare.net(FreyrInc) Regulatory Software FreyrInc To keep pace with Health Authority mandates and requirements, there is a dire need for Pharma/Biotech/Cosmetic/Medical Device manufacturers or organizations to automate their processes. There comes the requirement for Regulatory software which should be flexible, secured and cloud-hosted aligning with region specific submission formats and data requirements. As a specialist, Regulatory software provider Freyr offers proven tools for Publishing and submission, labeling, IDMP, Identity, Intelligence, document management and trial master files. Gain more knowledge on specialized Regulatory tools. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/regulatorysoftwareforslideshare-170413092213-thumbnail.jpg?width=120&height=120&fit=bounds" /> To keep pace with Health Authority mandates and requirements, there is a dire need for Pharma/Biotech/Cosmetic/Medical Device manufacturers or organizations to automate their processes. There comes the requirement for Regulatory software which should be flexible, secured and cloud-hosted aligning with region specific submission formats and data requirements. As a specialist, Regulatory software provider Freyr offers proven tools for Publishing and submission, labeling, IDMP, Identity, Intelligence, document management and trial master files. Gain more knowledge on specialized Regulatory tools.

Regulatory Software from Freyr Solutions

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0 FREYR UDI VISION SERIES SESSION 3 - DI & PI /slideshow/freyr-udi-vision-series-session-3-di-pi-05-dec-2014/43348425 freyrudivisionseriessession3-dipi05dec2014-150109032522-conversion-gate01
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits]]>
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits]]> Fri, 09 Jan 2015 03:25:22 GMT /slideshow/freyr-udi-vision-series-session-3-di-pi-05-dec-2014/43348425 FreyrInc@slideshare.net(FreyrInc) FREYR UDI VISION SERIES SESSION 3 - DI & PI FreyrInc As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/freyrudivisionseriessession3-dipi05dec2014-150109032522-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds" /> As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits

FREYR UDI VISION SERIES SESSION 3 - DI & PI from Freyr Solutions

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0 FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING /slideshow/freyr-udi-vision-series-session-2-labeling-barcoding-21-nov-2014/43348364 freyrudivisionseriessession2-labelingbarcoding21nov2014-150109032245-conversion-gate01
This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.]]>
This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.]]> Fri, 09 Jan 2015 03:22:45 GMT /slideshow/freyr-udi-vision-series-session-2-labeling-barcoding-21-nov-2014/43348364 FreyrInc@slideshare.net(FreyrInc) FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING FreyrInc This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/freyrudivisionseriessession2-labelingbarcoding21nov2014-150109032245-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds" /> This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.

FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING from Freyr Solutions

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0 FREYR UDI VISION SERIES SESSION 1 - UDI READINESS /slideshow/freyr-udi-vision-series-session-1-udi-readiness-14-nov-2014/43348123 freyrudivisionseriessession1-udireadiness14nov2014-150109031425-conversion-gate01
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.]]>
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.]]> Fri, 09 Jan 2015 03:14:25 GMT /slideshow/freyr-udi-vision-series-session-1-udi-readiness-14-nov-2014/43348123 FreyrInc@slideshare.net(FreyrInc) FREYR UDI VISION SERIES SESSION 1 - UDI READINESS FreyrInc Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/freyrudivisionseriessession1-udireadiness14nov2014-150109031425-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.

FREYR UDI VISION SERIES SESSION 1 - UDI READINESS from Freyr Solutions

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0 https://cdn.slidesharecdn.com/profile-photo-FreyrInc-48x48.jpg?cb=1570377491 Freyr is a fast-growing, Global Regulatory Solutions and Services company, exclusively focusing on the entire Regulatory value-chain of Life Sciences companies. Freyr offers Consulting, Software & Operations Outsourcing Services of Regulatory Affairs, Operations & Information Management functions to Large & Small-Medium Life Sciences companies. Freyr specializes in offering high-value Regulatory Solutions & Services in a highly cost-effective onsite/offshore outsourcing model. Have a business query? Let’s talk. Email: sales@freyrsolutions.com - Call: +1 908 483 7958 freyrsolutions.com https://cdn.slidesharecdn.com/ss_thumbnails/freyrcerwebinarpromotion-190415081336-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/clinical-evaluation-report-cer-decode-the-stepwise-approach-for-compliance/140845807 Clinical Evaluation Re... https://cdn.slidesharecdn.com/ss_thumbnails/regulatorylabelingchallenges-170511103045-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/regulatory-labeling-and-the-industry-challenges/75882984 REGULATORY LABELING AN... https://cdn.slidesharecdn.com/ss_thumbnails/regulatorysoftwareforslideshare-170413092213-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/regulatory-software/74973877 Regulatory Software