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Easing the Outsider Access Audit

Fernando Sosa at HaonTech.com and Camille Shipes Childs at U.S. Dermatology Partners

Healthcare organizations are regularly opening up their networks to an increasing number of third parties. Sadly, the access granted to third parties ...

3 weeks ago 58 mins

Drug and Device Development Secrets in the World of Medical Aesthetics

Jasmina Jankicevic, MD, MSc, CCRP, Dermatologist, Nach Davé, RPh, Marlis Sarkany, MD, MSc

New treatment options for aesthetic indications are in record-high demand, fueled by an aging population, and a growing focus on aesthetic issues rela...

8 months ago 61 mins

Essential Strategies in Dermatology Clinical Trials

Jasmina Jankicevic, MD, Vice President, Medical Affairs & Asya Tsaneva-Maksimova, Director Study Start-up

Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design Competition for patients among sponso...

1 year ago 62 mins

미용 의학세계의의약품 및 의료기기개발의 비밀

Jasmina Jankicevic, 피부과 전문의, 의학박사(MD), 이학석사, 국제 임상연구 전문가(CCRP)*, Nach Davé, 약사(RPh.)*, 이학석사, Marlis Sarkany, 의학박사(MD), 이학석사

미용 의학의 트렌드: 미용 의학 트렌드, 미용 의학 및 의료 기기 개발, 특히 지난 20 년 동안 미용 시장이 어떻게 진화하고 성장해 왔는지에 초점을 맞출 것입니다. 생리 기능 저하, 환경 스트레스에 대한 적응력 감소, 라이프 스타일이 피부 건강에 미치는 영향에 대한 ...

10 months ago 51 mins

Asia-Pacific – Taking Device Clinical Development to the US & Europe

Nach Dave, RPh. MSc, Vice President, Development Strategy and Marlis Sarkany, MD Senior Medical Director

Medical devices play an increasingly critical role in the health and quality of life for millions of people worldwide. While clinical trials for medic...

1 year ago 61 mins

미용 의학세계의의약품 및 의료기기개발의 비밀

Jasmina Jankicevic, 피부과 전문의, 의학박사(MD), 이학석사, 국제 임상연구 전문가(CCRP)*, Nach Davé, 약사(RPh.)*, 이학석사, Marlis Sarkany, 의학박사(MD), 이학석사

미용 의학의 트렌드: 미용 의학 트렌드, 미용 의학 및 의료 기기 개발, 특히 지난 20 년 동안 미용 시장이 어떻게 진화하고 성장해 왔는지에 초점을 맞출 것입니다. 생리 기능 저하, 환경 스트레스에 대한 적응력 감소, 라이프 스타일이 피부 건강에 미치는 영향에 대한 ...

10 months ago 51 mins

Rare Oncology Research in the 21st Century

Sachin Kulkarni and Juliet M. Moritz

Study of rare cancers tends to look more like rare disease research than standard oncology research. This webinar will highlight some of the challenge...

2 years ago 61 mins

From Startup to Launch in Just One Month, With Study Start-Up

Meghan Donahue, Study Start-Up Product Owner, Remarque Systems & Andrea Ochoa, VP, Global Study Start-Up, Premier Research

Start-up is a crucial time in any clinical study. It can also be chaotic. Developing protocols, choosing sites, onboarding patients—every step can hav...

9 months ago 32 mins

Natural History or Registry Study? Conducting Rare Disease Research

Angi Robinson and Juliet Moritz

Sound drug development requires a comprehensive understanding of the disease being treated. To design reliable clinical studies and achieve meaningful...

2 years ago 61 mins

The Potential For Disease-Modifying Therapies In Parkinson’s Disease

Andreas Schreiner and Barry Dussault

Parkinson’s disease is a progressive neurodegenerative disease that strikes its victims in the prime of their lives. Most available treatments have re...

2 years ago 62 mins

Conclusive Results: Strategies for Collecting Quality Data in Psychiatric Clinic

Krista Armstrong

Ensuring that psychiatry clinical trial data accurately captures a compound’s safety and efficacy potential requires an approach that accounts for cha...

2 years ago 64 mins

Considerations for Practical Execution of a RBQM Strategy

Crystal Stone, Director, Customer Engagement and Amanda Coogan, Product Specialist

Today, risk-based quality management (RBQM) of your clinical trial can be simple thanks to both integrated and standalone technology solutions. Such t...

10 months ago 44 mins

Operational & Regulatory Factors in Cross-Border Enrollment in Rare Disorders

Hanna Wide Director, Program Delivery Rare Diseases & Pediatrics at Premier Research

Researchers are more focused than ever on finding treatments and cures for rare diseases, encouraged by a regulatory environment that is increasingly ...

1 year ago 19 mins

FDA 허가 프로세스 505(b)(2) 경로, 이것은 무엇인가요? Pre-IND와 NDA제출(Submission)은 무엇을 의미하나요?

Ken Phelps 회장 & 창립자

- 505(b)(2) 제품 식별 - pre-IND 및 NDA 준비 및 제출을 포함한 505(b)(2) 제품에 대한 임상 규정 마일스톤 탐색 - 505(b)(2)와 관련된 자주 묻는 질문(FAQ)과 일반적인 오해 해결

5 months ago 35 mins

초기 종양학 연구에서 적응적 임상시험 디자인 (Adaptive Trial Design)의 역할: 유연성과 민첩성의 최적화

Abie Ekangaki, 박사(PhD) 부회장 생물통계학 컨설팅 담당 Peter J. Larson, 의사(MD) 전무이사 의료 담당

우리는 종양학 정밀 의학 연구에서 적응적 임상시험 디자인의 역할에 대한 몇 가지 높은 수준의 통찰력을 제시할 것입니다. 이러한 적응적 임상시험 디자인이 유연성과 민첩성을 최적화하는데 어떻게 도움이 되는지 알아보고자 합니다. 이것은 몇 가지 관점을 제시하고 향후 디자인 ...

6 months ago 44 mins

Planning for Quality in Medical Device Trials

Kristen Welz and Vicki Gashwiler

The concept of risk-based monitoring (RBM) has been discussed, implemented and refined in the pharmaceutical and medical device worlds for more than a...

2 years ago 58 mins

Novel Trial Approaches for Rare Cancer Patients

Rupa Doshi, PhD, Executive Director – Program Strategy, Oncology and Sameena Sharif, PhD, Senior Vice President, Product Stra

Best practices for managing ongoing cell and gene therapy trials Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no un...

1 year ago 58 mins

PACS Archiving Concerns and Implications

Eric Rice, CTO, Mach7 Technologies and Brian Philips, Chief Solutions Architect, NETSCOUT

HIMSS Chapter of Arizona is excited to announce Webinar: PACS Archiving Discussion. NETSCOUT is co-hosting and has provided the webinar services her...

4 years ago 61 mins

종합 분석 : 소아임상연구 진행 시 고려 사항

Jonathan Kornstein, 희귀 질환 및 소아임상 프로그램 전략 전무이사

소아임상연구 진행 시 주요과제와 대응 방안을 모색하기 위한 전문가 의견 *웨비나: 인터넷상의 세미나 소아의 특수성 때문에 소아 임상시험은 성인 임상시험과 다른 많은 문제점이 있습니다. 과제는 윤리, 생리학, 약리학, 경제학 및 소아의 낮은 신진대사, 많은 약물에 대...

12 months ago 33 mins

Considerations in Conducting Pediatric Clinical Trials

Jonathan Kornstein and Heather McKenney

There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often...

2 years ago 57 mins

Developing Best Practices for Forging Strategic Sponsor-CRO Partnerships

Krista Armstrong

Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partne...

2 years ago 30 mins

Strengthening Neuroscience Clinical Research Through Innovation

Juliet Moritz and Barry Dussault

There’s a lot of discussions these days about innovative ideas to make clinical research more patient-focused. The concept goes hand-in-hand with the ...

2 years ago 63 mins

FDA 505(b)(2) 경로 : 더 빠른 임상단계의 진입

Ken Phelps President & Founder

이 웨비나에서 Ken Phelps, 사장/설립자는 505(B)(2)경로에 대한 몇 가지 일반적인 오해를 다룰 것입니다. 대부분의 사람들은 스폰서가 모든 연구를 수행하며, 승인을 위한 매우 잘 확립된 경로가 있는 전통적인 약물 개발인 505(B)(1)경로에 대해 많은 경...

3 months ago 33 mins

The Powerful and Evolving Role of Patient Advocacy Groups in Clinical Research

Juliey Moritz

A major goal of patient advocacy groups is to address the unmet needs of patients with cancer or rare diseases by providing access to the most effecti...

2 years ago 63 mins

Improving Regulatory and Operational Performance in Orphan Drug Development

Nach Davé and Kimberly Glen

Today more than ever, regulatory bodies are providing a progressive platform for rare disease drug development. Extensions to existing regulations and...

2 years ago 57 mins

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