Monday, June 26, 2017
10:00 - 11:30 AM
The CORE Reference Session
CORE Reference was launched in May 2016, to provide interpretational guidance on ICH E3-based CSR authoring that incorporates real-world insights. These include guidance on writing CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. Data disclosure and transparency have become an important concept in new guidance from FDA and EMA. Since its introduction, CORE Reference has been downloaded over 5,400 times. Additionally, there have been a number of other important developments in the area of clinical trial disclosure. Redacted CSRs for over ten products have been published on the EMA’s website. This past December, EMA held a webinar to provide an update on the implementation of the clinical data publication Policy 0070. In February 2017, the Transcelerate Clinical Data Transparency team published three papers on practical implementation of clinical data transparency. Using CORE Reference, along with information from these other recent developments, attendees will be given strategies that can be applied to proactive preparation of CSRs for uses that require redacted personally-identifiable information and company confidential information.
11:30 AM - 1:00 PM
Lunch Break (included)
1:00 - 4:30 PM
AMWA Workshop: Serving Two Masters- Comparing and Contrasting US & EU Regulatory Processes with Art Gertel
There is now an internationally agreed format for the presentation of an application dossier for a marketing authorization for a pharmaceutical product: The Common Technical Document (CTD). It is accepted by the three participating regulating authorities (USA, EU, and Japan) as well as by other “observer” parties (e.g. Canada). This does not mean, however that there is commonality in the processes required for submission and review, the content of dossiers, nor the way in which reviewers approach the assessment of the dossier. In particular, there are significant differences between the way data are summarized and the approach taken by European reviewers and that taken by their counterparts in the USA. While some of these differences may ultimately evolve to a state of commonality, others likely never will. Participants will be introduced to the legal origins and mandates, and will review some of the labyrinthine procedures associated with preparing, filing, and defending a licensing application. Cultural and practice differences and similarities between the EU and USA will be explored.
There will be a networking social event on Monday, June 26th starting at 5:30 in Rockville, MD at That's Amore Restaurant. Please RSVP to Mid-Atlantic Chapter President Erin Boyle at firstname.lastname@example.org.
Tuesday, June 27, 2017
9:00 AM – 12:00 PM
AMWA Workshop: Regulatory Aspects of the Drug Development Process for Medical Writers with Aaron Bernstein
This workshop is designed for novices to the pharmaceutical industry. Participants will learn about and discuss the drug development process with special emphasis given to regulatory and reporting requirements. Specifically, the workshop details the history behind drug regulation, the contents and maintenance of an Investigational New Drug Application (IND), Good Clinical Practice (GCP), the phases of human clinical trials, and the most recent regulations impacting drug development. The discussion will draw upon US, European, and International Conference on Harmonisation (ICH) guidelines and regulations.
12:00 – 1:30 PM
Lunch Break (included)
1:30 - 5:00 PM
AMWA Workshop: Fundamentals of Ethics and Practical Applications with Art Gertel
Ethical considerations associated with conducting clinical research will be explored in this workshop intended for medical writers, editors, and researchers with some experience/familiarity with regulated therapeutic development activities. The workshop will consist of short presentations on relevant ethical issues with respect to therapeutic (drug, device, vaccine) clinical trials and group discussions on major ethical considerations of some case studies. Topics include the importance of ethics in good clinical practice (GCP), the informed consent process and the challenges that may arise in developing countries, the infrastructure of ethics committees, and data safety monitoring committees. Throughout, the workshop will focus on the central ethical issue in clinical study conduct: to ensure subject safety and well-being.
The CORE Reference Session $45
AMWA Workshops $175 each (AMWA member price) / $200 each (nonmember price)