271 Courses delivered Online

The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

Physiotherapy in ICU Guidelines Aims to  Acute Care and ICU Physical Therapy is a growing area of practice. This course is geared toward both the new/entry-level and advanced practice therapist to integrate the complexity of lines, tubes, and monitoring devices and optimize them to advance treatment options with patients. Learning Objectives At the end of this course, the participant will be able to: 1.Integrate information on invasive lines, tubes, and monitoring devices with patient presentation 2.Consider acute care and ICU safety guidelines for physical and occupational therapy intervention and exercise on the impact of patient care and outcomes 3.Explain physiological responses to exercise in order to safely monitor patients during ”high-intensity” treatment 4.Demonstrate integration and application of acute care competencies: safety, sound clinical decision-making, communication, and discharge planning  5.Discuss treatment approaches to creatively optimize patient physical functioning in the acute and ICU setting Who Should Enroll Physiotherapist Allied Healthcare professionals ICU nurses Course Agenda Introduction- 10 minutes Acute Care and ICU Safety and Feasibility- 15 minutes Lines, Tubes, and Monitors- 15 minutes Early Mobility and Physiological Response to Exercise in Critically Ill Patients- 20 minutes Case Presentation- 25 minutes Creative Treatment Approaches for the Acute/ICU Patient- 25 minutes Conclusion/Questions- 10 minutes Total: 120 minutes  CPD Credit Hours 2.0 Hours Resources 1-Month Access to Learning Resources Downloadable Course Material  CPD Certificate Presenter Speaker Bio: Katelyn Whitlock, PT, DPT Dr. Katelyn Whitlock is a practicing cardiovascular and pulmonary acute care and ICU physical therapist in Atlanta, GA. She graduated from Emory University’s Doctor of Physical Therapy Program in May of 2018. Following her DPT she completed the Emory Acute Care Residency in 2019. Prior to her DPT, she earned her bachelor's and master's degrees in Exercise Physiology from the University of Virginia. Currently, she is a primary therapist on the Heart Transplant, Lung Transplant, LVAD and ECMO team at EUH, is a course instructor in the DPT program at Philadelphia College of Osteopathic Medicine for Cardiovascular and Pulmonary Clinical Management and Pharmacology courses, and has ongoing research in the areas of ICU Physical Therapy and COVID-19. She sat for her Cardiovascular and Pulmonary Specialist Exam in February of 2022. Course Instructor About Physiotherapy Online Physiotherapy Online is a physiotherapist-owned educational company with a vision to create an ensemble of international educators to cater to undergraduate, postgraduate physiotherapy students as well as post professionals who are keen to advance or refesh their existing knowledge in varied specialities. As every student has a unique approach to learning, we have therefore created a library of bite sized chapters which may be accessed as an individual module or a course as a whole; self study webinars; live workshops for those who would like to get an in-person hands on immersive experience and audio books for those on the go.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.

This module describes the design, development and installation phase, the validation phase, and the operation and maintenance phase of the validation of computerised systems in medicines and healthcare products manufacturing environments. It continues to follow the progress of a pharmaceutical company's project to validate a new dispensary control system.

In the medicines and healthcare products industries, computerised systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This module describes the planning of such validation. It follows the work of a pharmaceutical company's team as they validate the dispensary control system for a new production line.

Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning programme. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company's validation team as they establish and validate the cleaning program for a new production line.

Having undergone Installation Qualification, before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This module describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.