Remove Documentation Remove Drug Development Remove Workshop
article thumbnail

SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference

pharmaphorum

Workshops: 29 April 2022. SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference is taking place in Boston on April 27-28, 2022, with interactive workshops on April 26, 2022. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the field.

article thumbnail

Patient Experience Data and the Need for Patient Experience Dossiers

Putting Patients First Blog

hosted a series of workshops with patients, patient organizations, industry, and other stakeholders to develop a document known as the ‘Patient Experience Dossier’ (PED). In addition, patient experience data has also been included as part of the 21 st Century Cures Act which would assist the U.S.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pre-Filled Syringes East Coast 2022

pharmaphorum

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Drug developers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Workshop Leader: Theresa Jeary, Technical Specialist & Scheme Manager, BSi. SMi’s 9th Annual Conference. Pre-Filled Syringes East Coast.

article thumbnail

Skill building: Rx for R&D

Express Pharma

Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D. References [link] [link] 281%29.pdf

article thumbnail

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Biosimilars

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

article thumbnail

Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog: Biosimilars

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

article thumbnail

NHC Comments on Key Information and Facilitating Understanding in Informed Consent

Putting Patients First Blog

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.