Good Science vs. Bad Writing: Strategies for Building an Effective Scientific Writing Team
1:00:19
Good Science vs. Bad Writing: Strategies for Building an Effective Scientific Writing Team
2 ай бұрын
Ask the Expert: The Role of Real-World Evidence (RWE) in Regulatory Submissions
36:11
Ask the Expert: The Role of Real-World Evidence (RWE) in Regulatory Submissions
3 ай бұрын
Emerging Trends in Global Regulations: Insights Into More Efficient Regulatory Writing Practices
54:37
Emerging Trends in Global Regulations: Insights Into More Efficient Regulatory Writing Practices
3 ай бұрын
Pharma In Focus: The Role of Real-World Evidence (RWE) in Regulatory Submissions
45:45
Pharma In Focus: The Role of Real-World Evidence (RWE) in Regulatory Submissions
4 ай бұрын
Trending Topics: From the AI Act to Orphan Devices, Key Takeaways from RAPS EU Convergence 2024
46:15
Trending Topics: From the AI Act to Orphan Devices, Key Takeaways from RAPS EU Convergence 2024
4 ай бұрын
Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
52:08
Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
5 ай бұрын
Understanding FDA: Essentials for Briefing Books in Pre-IND, Pre-NDA, and Pre-BLA Meetings
59:31
Understanding FDA: Essentials for Briefing Books in Pre-IND, Pre-NDA, and Pre-BLA Meetings
6 ай бұрын
IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
53:57
IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
6 ай бұрын
Practical Strategies to Successfully Navigate Key IVDR Regulations Applicable to SaMD Devices
48:17
Practical Strategies to Successfully Navigate Key IVDR Regulations Applicable to SaMD Devices
10 ай бұрын
How Much Data is “Sufficient”? Navigating Clinical Evidence Requirements Under the MDR and IVDR
1:02:18
How Much Data is “Sufficient”? Navigating Clinical Evidence Requirements Under the MDR and IVDR
10 ай бұрын
Ask The Expert: IVDR - Early Experience and Feedback
35:26
Ask The Expert: IVDR - Early Experience and Feedback
Жыл бұрын
Pro Tips Unveiled: Expert Systematic Literature Review Strategies for EU IVDR Submissions
58:44
Pro Tips Unveiled: Expert Systematic Literature Review Strategies for EU IVDR Submissions
Жыл бұрын
It's All Interconnected - Hidden Traps That Can Derail Your PER
1:02:38
It's All Interconnected - Hidden Traps That Can Derail Your PER
Жыл бұрын
IVDR Readiness: Creating a Blueprint to Build a Strong PER
56:02
IVDR Readiness: Creating a Blueprint to Build a Strong PER
Жыл бұрын
Ask the Expert: Plain Language Content - Effective Communication for Patients, Caregivers, and HCPs
43:19
Ask the Expert: Plain Language Content - Effective Communication for Patients, Caregivers, and HCPs
Жыл бұрын
Integration of Plain Language Content and Infographics: Strategies to Enhance HCP Engagement
50:15
Integration of Plain Language Content and Infographics: Strategies to Enhance HCP Engagement
Жыл бұрын
Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCPs
58:42
Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCPs
Жыл бұрын
Critical Concepts Medical Device Software: Risk Class, Qualification, & Safety/Performance Outcomes
25:24
Critical Concepts Medical Device Software: Risk Class, Qualification, & Safety/Performance Outcomes
Жыл бұрын
Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
57:37
Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
Жыл бұрын
Ask the Expert: Requirements & Challenges of Plain Language Content Creation for Multiple Audiences
49:11
Ask the Expert: Requirements & Challenges of Plain Language Content Creation for Multiple Audiences
Жыл бұрын
Plain Language Communication in Healthcare - Part 1: Understanding Requirements and Challenges
1:01:15
Plain Language Communication in Healthcare - Part 1: Understanding Requirements and Challenges
Жыл бұрын
New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
58:36
New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
Жыл бұрын
ATE: 2023 MDR/IVDR Submission Readiness: Getting Your Ducks in a Row from the Writer’s Perspective
46:10
ATE: 2023 MDR/IVDR Submission Readiness: Getting Your Ducks in a Row from the Writer’s Perspective
Жыл бұрын
Ask the Expert: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
44:42
Ask the Expert: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
2 жыл бұрын
Critical Concepts: Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
56:52
Critical Concepts: Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
2 жыл бұрын
Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
56:40
Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
2 жыл бұрын
MedTech Digital Week: The Role of RA in the Clinical and Performance Evaluation Process
59:19
MedTech Digital Week: The Role of RA in the Clinical and Performance Evaluation Process
2 жыл бұрын
Ask the Expert: CER Critical Concepts
48:05
Ask the Expert: CER Critical Concepts
2 жыл бұрын
CER Critical Concepts: Effectively Telling the Story of the Clinical Evaluation Report
58:33
CER Critical Concepts: Effectively Telling the Story of the Clinical Evaluation Report
2 жыл бұрын
Пікірлер
@deafoulger4947
@deafoulger4947 9 ай бұрын
⭐ Promo*SM
@mahmoudalabsy7610
@mahmoudalabsy7610 9 ай бұрын
سبحان الله وبحمده سبحان الله العظيم رب العرش العظيم عدد خلقه ورضا نفسه وزنة عرشه ومداد كلماته
@GBZChristianGBZ
@GBZChristianGBZ Жыл бұрын
This is a great webinar which answers a lot of questions one might have regarding SoA and SV in general. Is the scope of what is expected for SV under IVDR much bigger than what the current FDA guidance's point to? Also, terminology wise, what is SV referred to in CDRH terms?
@lcprezende
@lcprezende 2 жыл бұрын
Excellent explanation, thank you so much!
@amarnathmullapudi2789
@amarnathmullapudi2789 3 жыл бұрын
Informative and excellent webi nar!
@druginfos
@druginfos 4 жыл бұрын
You are so good in educating. Keep doing such videos. Thank you ver much!!!