�ݺ�ߣshows by User: VoisinConsultingLifeSciences

�ݺ�ߣshows by User: VoisinConsultingLifeSciences / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: VoisinConsultingLifeSciences / Mon, 14 Sep 2020 12:30:37 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: VoisinConsultingLifeSciences How to overcome the regulatory challenges due to brexit /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit-238479591/238479591 howtoovercometheregulatorychallengesduetobrexit-200914123037
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]>
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]> Mon, 14 Sep 2020 12:30:37 GMT /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit-238479591/238479591 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) How to overcome the regulatory challenges due to brexit VoisinConsultingLifeSciences This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/howtoovercometheregulatorychallengesduetobrexit-200914123037-thumbnail.jpg?width=120&height=120&fit=bounds" /> This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.

How to overcome the regulatory challenges due to brexit from Voisin Consulting Life Sciences

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0 How to overcome the regulatory challenges due to brexit.pptx /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexitpptx/238479396 howtoovercometheregulatorychallengesduetobrexit-200914121431
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]>
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]> Mon, 14 Sep 2020 12:14:31 GMT /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexitpptx/238479396 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) How to overcome the regulatory challenges due to brexit.pptx VoisinConsultingLifeSciences This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/howtoovercometheregulatorychallengesduetobrexit-200914121431-thumbnail.jpg?width=120&height=120&fit=bounds" /> This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.

How to overcome the regulatory challenges due to brexit.pptx from Voisin Consulting Life Sciences

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0 How to overcome the regulatory challenges due to brexit /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit-238479331/238479331 howtoovercometheregulatorychallengesduetobrexit-200914120842
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]>
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]> Mon, 14 Sep 2020 12:08:42 GMT /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit-238479331/238479331 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) How to overcome the regulatory challenges due to brexit VoisinConsultingLifeSciences This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/howtoovercometheregulatorychallengesduetobrexit-200914120842-thumbnail.jpg?width=120&height=120&fit=bounds" /> This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.

How to overcome the regulatory challenges due to brexit from Voisin Consulting Life Sciences

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0 How to overcome the regulatory challenges due to BREXIT /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit/238476130 slidesforsharingwithparticipants003-200914095201
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]>
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.]]> Mon, 14 Sep 2020 09:52:00 GMT /slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit/238476130 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) How to overcome the regulatory challenges due to BREXIT VoisinConsultingLifeSciences This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/slidesforsharingwithparticipants003-200914095201-thumbnail.jpg?width=120&height=120&fit=bounds" /> This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.

How to overcome the regulatory challenges due to BREXIT from Voisin Consulting Life Sciences

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0 VCLS microbiome workshop_short /slideshow/vcls-microbiome-workshopshort/141006210 vclsmicrobiomeworkshopshort-190416133829
What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A transnational perspective -Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements; -Microbiome products NC evaluation compared to drugs/ biologics NC evaluation: same objectives but different strategies; - Regulatory NC considerations and approach; -Take-home messages: integrated approach CMC / nonclinical / clinical ]]>
What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A transnational perspective -Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements; -Microbiome products NC evaluation compared to drugs/ biologics NC evaluation: same objectives but different strategies; - Regulatory NC considerations and approach; -Take-home messages: integrated approach CMC / nonclinical / clinical ]]> Tue, 16 Apr 2019 13:38:29 GMT /slideshow/vcls-microbiome-workshopshort/141006210 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) VCLS microbiome workshop_short VoisinConsultingLifeSciences What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A transnational perspective -Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements; -Microbiome products NC evaluation compared to drugs/ biologics NC evaluation: same objectives but different strategies; - Regulatory NC considerations and approach; -Take-home messages: integrated approach CMC / nonclinical / clinical <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/vclsmicrobiomeworkshopshort-190416133829-thumbnail.jpg?width=120&height=120&fit=bounds" /> What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A transnational perspective -Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements; -Microbiome products NC evaluation compared to drugs/ biologics NC evaluation: same objectives but different strategies; - Regulatory NC considerations and approach; -Take-home messages: integrated approach CMC / nonclinical / clinical

VCLS microbiome workshop_short from Voisin Consulting Life Sciences

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0 Regulatory And Development Strategies For Gene & Cell Thaerapies /slideshow/regulatory-and-development-strategies-for-gene-cell-thaerapies/135892777 isbiotechvclswebsite-190312161455
Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Rare diseases can be chronic, progressive, degenerative, and often life-threatening. Given the small patient populations, traditional development pathways may not be relevant or necessary, requiring novel and innovative approaches. From a market access perspective, lack of comparative effectiveness and long-term outcomes data can lead to delays in reimbursement and significant post-launch evidence generation commitments. Treatment costs and patient benefits may not be matched over time giving rise to difficulties with assessing the value and establishing the necessary funding pathways. VCLS is at the forefront of designing new strategies to bring effective and timely treatments to patients in these high unmet need rare disease areas. This presentation provides an outline for smarter orphan drug development through: • Integrating development approach • Reducing cost and time • Maximizing patient access]]>
Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Rare diseases can be chronic, progressive, degenerative, and often life-threatening. Given the small patient populations, traditional development pathways may not be relevant or necessary, requiring novel and innovative approaches. From a market access perspective, lack of comparative effectiveness and long-term outcomes data can lead to delays in reimbursement and significant post-launch evidence generation commitments. Treatment costs and patient benefits may not be matched over time giving rise to difficulties with assessing the value and establishing the necessary funding pathways. VCLS is at the forefront of designing new strategies to bring effective and timely treatments to patients in these high unmet need rare disease areas. This presentation provides an outline for smarter orphan drug development through: • Integrating development approach • Reducing cost and time • Maximizing patient access]]> Tue, 12 Mar 2019 16:14:55 GMT /slideshow/regulatory-and-development-strategies-for-gene-cell-thaerapies/135892777 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) Regulatory And Development Strategies For Gene & Cell Thaerapies VoisinConsultingLifeSciences Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Rare diseases can be chronic, progressive, degenerative, and often life-threatening. Given the small patient populations, traditional development pathways may not be relevant or necessary, requiring novel and innovative approaches. From a market access perspective, lack of comparative effectiveness and long-term outcomes data can lead to delays in reimbursement and significant post-launch evidence generation commitments. Treatment costs and patient benefits may not be matched over time giving rise to difficulties with assessing the value and establishing the necessary funding pathways. VCLS is at the forefront of designing new strategies to bring effective and timely treatments to patients in these high unmet need rare disease areas. This presentation provides an outline for smarter orphan drug development through: • Integrating development approach • Reducing cost and time • Maximizing patient access <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/isbiotechvclswebsite-190312161455-thumbnail.jpg?width=120&height=120&fit=bounds" /> Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Rare diseases can be chronic, progressive, degenerative, and often life-threatening. Given the small patient populations, traditional development pathways may not be relevant or necessary, requiring novel and innovative approaches. From a market access perspective, lack of comparative effectiveness and long-term outcomes data can lead to delays in reimbursement and significant post-launch evidence generation commitments. Treatment costs and patient benefits may not be matched over time giving rise to difficulties with assessing the value and establishing the necessary funding pathways. VCLS is at the forefront of designing new strategies to bring effective and timely treatments to patients in these high unmet need rare disease areas. This presentation provides an outline for smarter orphan drug development through: • Integrating development approach • Reducing cost and time • Maximizing patient access

Regulatory And Development Strategies For Gene & Cell Thaerapies from Voisin Consulting Life Sciences

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0 201710 market access for cgt ng_cj_summary /slideshow/201710-market-access-for-cgt-ngcjsummary/81019988 201710marketaccessforcgtngcjsummary-171020144357
Carole Jones & Gopalan Narayanan share their insights on commercialization of Advanced Therapy Medicinal Products (ATMPs) at the Market Access for Cell and Gene Therapies Conference on October 19th 2017.]]>
Carole Jones & Gopalan Narayanan share their insights on commercialization of Advanced Therapy Medicinal Products (ATMPs) at the Market Access for Cell and Gene Therapies Conference on October 19th 2017.]]> Fri, 20 Oct 2017 14:43:57 GMT /slideshow/201710-market-access-for-cgt-ngcjsummary/81019988 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) 201710 market access for cgt ng_cj_summary VoisinConsultingLifeSciences Carole Jones & Gopalan Narayanan share their insights on commercialization of Advanced Therapy Medicinal Products (ATMPs) at the Market Access for Cell and Gene Therapies Conference on October 19th 2017. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/201710marketaccessforcgtngcjsummary-171020144357-thumbnail.jpg?width=120&height=120&fit=bounds" /> Carole Jones & Gopalan Narayanan share their insights on commercialization of Advanced Therapy Medicinal Products (ATMPs) at the Market Access for Cell and Gene Therapies Conference on October 19th 2017.

201710 market access for cgt ng_cj_summary from Voisin Consulting Life Sciences

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0 201705 topra india_atmp_fb_slide_share /VoisinConsultingLifeSciences/201705-topra-indiaatmpfbslideshare 201705topraindiaatmpfbslideshare-171004140439
Florence Bine-Scheck, Senior Medical Director at VCLS, shares her insights on the clinical development of Advanced Therapy Medicinal Products (ATMPs)]]>
Florence Bine-Scheck, Senior Medical Director at VCLS, shares her insights on the clinical development of Advanced Therapy Medicinal Products (ATMPs)]]> Wed, 04 Oct 2017 14:04:39 GMT /VoisinConsultingLifeSciences/201705-topra-indiaatmpfbslideshare VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) 201705 topra india_atmp_fb_slide_share VoisinConsultingLifeSciences Florence Bine-Scheck, Senior Medical Director at VCLS, shares her insights on the clinical development of Advanced Therapy Medicinal Products (ATMPs) <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/201705topraindiaatmpfbslideshare-171004140439-thumbnail.jpg?width=120&height=120&fit=bounds" /> Florence Bine-Scheck, Senior Medical Director at VCLS, shares her insights on the clinical development of Advanced Therapy Medicinal Products (ATMPs)

201705 topra india_atmp_fb_slide_share from Voisin Consulting Life Sciences

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0 201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share /slideshow/201706-medtech-mdrclinicalevaluationinvestigationepslideshare/80455430 201706medtechmdrclinicalevaluationinvestigationepslideshare-171004135149
VCLS presentation from Emmanuel Prades at the MedTech Informa 2017 in Amsterdam]]>
VCLS presentation from Emmanuel Prades at the MedTech Informa 2017 in Amsterdam]]> Wed, 04 Oct 2017 13:51:49 GMT /slideshow/201706-medtech-mdrclinicalevaluationinvestigationepslideshare/80455430 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) 201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share VoisinConsultingLifeSciences VCLS presentation from Emmanuel Prades at the MedTech Informa 2017 in Amsterdam <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/201706medtechmdrclinicalevaluationinvestigationepslideshare-171004135149-thumbnail.jpg?width=120&height=120&fit=bounds" /> VCLS presentation from Emmanuel Prades at the MedTech Informa 2017 in Amsterdam

201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share from Voisin Consulting Life Sciences

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0 201709 phacilitate atmp_nc_perspectives_cecile r_slide_share /slideshow/201709-phacilitate-atmpncperspectivescecile-rslideshare/80455142 201709phacilitateatmpncperspectivescecilerslideshare-171004134506
VCLS presentation from Cécile Rousseau at the Phacilitate Cell & Gene Therapy Europe 2017]]>
VCLS presentation from Cécile Rousseau at the Phacilitate Cell & Gene Therapy Europe 2017]]> Wed, 04 Oct 2017 13:45:06 GMT /slideshow/201709-phacilitate-atmpncperspectivescecile-rslideshare/80455142 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) 201709 phacilitate atmp_nc_perspectives_cecile r_slide_share VoisinConsultingLifeSciences VCLS presentation from Cécile Rousseau at the Phacilitate Cell & Gene Therapy Europe 2017 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/201709phacilitateatmpncperspectivescecilerslideshare-171004134506-thumbnail.jpg?width=120&height=120&fit=bounds" /> VCLS presentation from Cécile Rousseau at the Phacilitate Cell & Gene Therapy Europe 2017

201709 phacilitate atmp_nc_perspectives_cecile r_slide_share from Voisin Consulting Life Sciences

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0 Overview of EU Regulatory Landscape for Regenerative Medicines /slideshow/overview-of-eu-regulatory-landscape-for-regenerative-medicines/78195955 201706regmedparisregenerativemedicineespsummary-170724135007
Regulatory constraints in the therapeutic field: from exploratory toxicology studies to regulatory studies, regulatory environment, protocol development, follow-up and interpretation of results, product / protocol constraints, GLP / GMP, Quality Control and Assurance, documents Required by Agencies before FIM (Investigator Brochure, IMPD), etc. Regulatory constraints in the field of diagnostics and medical device: CE marking and FDA approval, essential requirements.]]>
Regulatory constraints in the therapeutic field: from exploratory toxicology studies to regulatory studies, regulatory environment, protocol development, follow-up and interpretation of results, product / protocol constraints, GLP / GMP, Quality Control and Assurance, documents Required by Agencies before FIM (Investigator Brochure, IMPD), etc. Regulatory constraints in the field of diagnostics and medical device: CE marking and FDA approval, essential requirements.]]> Mon, 24 Jul 2017 13:50:07 GMT /slideshow/overview-of-eu-regulatory-landscape-for-regenerative-medicines/78195955 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) Overview of EU Regulatory Landscape for Regenerative Medicines VoisinConsultingLifeSciences Regulatory constraints in the therapeutic field: from exploratory toxicology studies to regulatory studies, regulatory environment, protocol development, follow-up and interpretation of results, product / protocol constraints, GLP / GMP, Quality Control and Assurance, documents Required by Agencies before FIM (Investigator Brochure, IMPD), etc. Regulatory constraints in the field of diagnostics and medical device: CE marking and FDA approval, essential requirements. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/201706regmedparisregenerativemedicineespsummary-170724135007-thumbnail.jpg?width=120&height=120&fit=bounds" /> Regulatory constraints in the therapeutic field: from exploratory toxicology studies to regulatory studies, regulatory environment, protocol development, follow-up and interpretation of results, product / protocol constraints, GLP / GMP, Quality Control and Assurance, documents Required by Agencies before FIM (Investigator Brochure, IMPD), etc. Regulatory constraints in the field of diagnostics and medical device: CE marking and FDA approval, essential requirements.

Overview of EU Regulatory Landscape for Regenerative Medicines from Voisin Consulting Life Sciences

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0 Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2 /slideshow/preparing-a-drug-registration-for-the-us-and-the-eu-parallel-or-sequential-applications-part-2/62459681 vclsslidesharenboeglindrugregistrationusandeupart2vf-160527093806
This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.]]>
This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.]]> Fri, 27 May 2016 09:38:06 GMT /slideshow/preparing-a-drug-registration-for-the-us-and-the-eu-parallel-or-sequential-applications-part-2/62459681 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2 VoisinConsultingLifeSciences This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/vclsslidesharenboeglindrugregistrationusandeupart2vf-160527093806-thumbnail.jpg?width=120&height=120&fit=bounds" /> This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2 from Voisin Consulting Life Sciences

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0 Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 1 /slideshow/preparing-a-drug-registration-for-the-us-and-the-eu-parallel-or-sequential-applications-part-1/62459677 vclsslidesharenboeglindrugregistrationusandeupart1vf-160527093802
Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen provide an overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.]]>
Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen provide an overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.]]> Fri, 27 May 2016 09:38:02 GMT /slideshow/preparing-a-drug-registration-for-the-us-and-the-eu-parallel-or-sequential-applications-part-1/62459677 VoisinConsultingLifeSciences@slideshare.net(VoisinConsultingLifeSciences) Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 1 VoisinConsultingLifeSciences Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen provide an overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/vclsslidesharenboeglindrugregistrationusandeupart1vf-160527093802-thumbnail.jpg?width=120&height=120&fit=bounds" /> Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen provide an overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 1 from Voisin Consulting Life Sciences

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0 https://cdn.slidesharecdn.com/profile-photo-VoisinConsultingLifeSciences-48x48.jpg?cb=1603444762 Voisin Consulting Life Sciences supports life science companies throughout product development and engages in communication with regulators and payers. We partner with Biotech, Pharma and Medtech manufacturers to develop, register and launch innovative products in North American and European markets. VCLS provides a unique suite of people-powered solutions to complement in-house resources, from strategy to tactical operations. www.voisinconsulting.com https://cdn.slidesharecdn.com/ss_thumbnails/howtoovercometheregulatorychallengesduetobrexit-200914123037-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit-238479591/238479591 How to overcome the re... https://cdn.slidesharecdn.com/ss_thumbnails/howtoovercometheregulatorychallengesduetobrexit-200914121431-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexitpptx/238479396 How to overcome the re... https://cdn.slidesharecdn.com/ss_thumbnails/howtoovercometheregulatorychallengesduetobrexit-200914120842-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/how-to-overcome-the-regulatory-challenges-due-to-brexit-238479331/238479331 How to overcome the re...