Training Services
Public Seminars
Focusing on solutions and practical advice, these public seminars cover even the "toughest topics" of local and global labeling, safety labeling in particular. Seminars are conducted by one or more instructors with outstanding qualifications and credentials and are worth attending for both beginners and experience professionals (e.g. heads of pharmacovigilance and labeling departments) who seek discussion about current trends and issues. Pre-defined seminar objectives and agenda ensure consistent quality, but seminars can be "personalized." Attendees can submit questions and topics of particular interest in advance and volunatry "dinner discussion groups" on special topics are an option upon request of attendees. Since these public seminars are highly interactive, we have limited the number of participants to ensure ample discussion time and peer-to-peer information exchange.
Who Should Attend Which Seminar?
- New members of labeling/regulatory, pharmacovigilance, medical or clinical departments who are involved in the labeling decision making process - located at headquarters or in a local (country) affiliate should first consider "Company Core Data Sheets and Core Safety Information"followed by "Safety Labeling - In-depth Review of Important Aspects". Opposite order is possible, but the "Company Core Data Sheets and Core Safety Information" seminar should not be skipped.
- New members of US regulatory affairs or labeling departments, pharmacovigilance professionals involved in US labeling activities, non-US labeling/regulatory and pharmacovigilance professionals who must understand US safety labeling (e.g. members of a global labeling department located in Europe or Japan) should attend"US Prescribing Information with Highlights - US Safety Labeling".
- Professionals involved in labeling process design and improvement, auditors should consider"Global Labeling Process Design and Evaluation," as this seminar covers good process design practices for both headquarters and local (e.g. US). It does not, however, cover labeling processes in the manufacturing area (subject to GMP).
- Anyone looking for an update on core or local labeling regulations, guidelines or best practices should refer to the seminar descriptions and agendas and chose the seminar that best serves your needs.
If you are unsure which seminar serves your needs best, call our offices.
We are proud that our seminars are attended by professionals from "around the world".
In-house Training
We offer:
- Our public seminars as in-house training events
- Client-specific, customized training on specific topics
Audiences:
- Executives: Presentations on policy/strategy options
- Project teams and departments
- On-the-job training/coaching of individual professionals
We have provided in-house training for labeling/regulatory and for pharmacovigilance departments in the United States, in Europe and in Japan.
New: In-house "Lunch and Learn"
In 2009, we will roll out the new training offering "Lunch and Learn". Using webinar technology, Pharmiceutics provides weekly or bi-weekly 1-hour training sessions for labeling, regulatory and pharmacovigilance departments.
Ideally held during lunch time, these sessions can take place at any other time of the day.
Ideal as initial training of new department members or for refresher training.
The Lunch and Learn program will focus on a systematic read-through regulations and guidelines, with detailed discussion of the meaning and the background of the agencies positions. A full train of sessions for US Prescribing Information will take about 30-40 sessions. Shorter trains for section of the regulations and guidelines can be arranged. Each session consists of approx. 30 minutes walk-through regulation and guideline text, and approx. 30 minutes of Q&A and discussion.
Only one single company can participate in a train of sessions to ensure confidentiality of Q&A and discussions. depending of the topic, most or all of the Lunch and Learn sessions will be performed by A. L. Fontaine. Therefore, the number of Lunch and Learn trains that can run in parallel is limited, i.e., we can only serve two or three companies per year.
Client-Specific Training
- We develop or assist in the development of training programs and materials for in-house training on a Client's policies, SOPs, internal labeling standards, regulations and regulatory guidelines.
- We deliver client-specific training to a Client's headquarters and affiliate staff.
- In collaboration with experienced associate consultants, as required
eTraining and eLearning Modules
The large number of employees involved in labeling activities, their geographical distribution, and staff turn-over constitute an ideal use case for eTraining on policies, SOPs, standards regulations and regulatory guidelines.
In collaboration with experienced associate consultants, we develop eLearning modules and eTraining programs.