In such turbulent times, pharmacovigilance has been also affected by the unexpected changes of the World. BREXIT and Trump tornado, what else to come? In order to stay up-to-date our 5th Annual Pharmacovigilance Forum is a perfect opportunity to hear the most important updates of the industry. We bring together the top minds of the pharmaceutical industry from all over Europe to share their experiences and best practices and to network with their peers. Topics such as BREXIT vs. Pharmacovigilance, effectiveness evaluation of risk minimization measures, signal detection and Eudravigilance, GVP guidance, significance of outsourcing and many more will be discussed and consulted during our event. For those interested in Biosimilars Dr. Niraj Chhaya from Boehringer Ingelheim GmbH will present the success factor of biosimilars.
We are also happy to welcome Andrew A. Parsons on board from Reciprocal Minds Limited who will talk about human factors in Pharma R&D. This is a special feature to the event which will be a great added value to the audience. Stay up-to-date and join our upcoming event to meet these leaders of the industry and listen their inspiring presentations in order to take home the most beneficial outcome for you and your company.
Discover the hot topic
PV as “science and art”
Listen to industry experts discussing the current pharmacovigilance ladnscape within Europe
Pharmacovigilance and the BREXIT
Learn more about the impact of BREXIT on PV within Europe
Artificial Intelligence in PV
Understand how AI will change the ecosystem of PV
Medical literature monitoring
Discuss the main impacts of EMA’s medical literature monitoring service
Gain an insight on the regulatory guidance on signal detection
PASS and PIP
Hear the best practices in design and conduct of PASS and PIP
You can credit training/learning hours towards your professional accreditation by participating on this CPD certified forum.
08:30 Welcome Coffee and Registration
09:00 Pharmacovigilance in the light of BREXIT
09:40 An overview of EMA MLM’s method of literature monitoring
10:20 Switzerland- still a special country; Tips for an successful Pharmacovigilance Inspection
11:00 Tea, Coffee, Networking & Exhibits
11:30 Practical advice on the planning and conduct of Pharmacovigilance audits in small and medium-sized enterprises (SMEs)
12:10 Current regulatory trends in PASS and PIP studies
12:50 Effectiveness Evaluation of Risk Minimization Measures: a Case Study
13:30 Luncheon & Networking
14:30 Reclassifying medicines for OTC: Assessing benefit-risk and risk minimization in a consumer setting
15:10 Human Factors – Optimising the usability of processes and technology in Pharma R&D
15:50 Tea, Coffee, Networking & Exhibits
16:20 Why does pharmacovigilance sometimes fail and where could the fault lie?
17:00 Pharmacovigilance of Antibiotics
17:40 Closing Remarks from the Chair & Networking
08:30 Meet, Greet & Networking with Welcome Coffee
09:00 Signal Detection an Eudravigilance
09:40 Signal Management – revised GVP guidance
10:20 Web-based signal detection
11:00 Tea, Coffee, Networking & Exhibits
11:20 Pharmacovigilance : The patient Perspective
12:10 Safety aspects of Patient Support Programmes and other Customer Engagement Activities
12:50 Luncheon & Networking
13:50 Pharmacovigilance for Biosimilars
14:30 Significance of outsourcing and its effectiveness
15:10 Tea, Coffee, Networking & Exhibits
15:40 Safety Alerts: An Observational Study
16:20 Holistic Approach to Combination Product Safety
17:00 Closing Remarks from the Chair & Farewell Networking
Senior Pharmacovigilance Regulators and Inspectors, Pharmacovigilance and Drug Safety Officers, Regulatory Affairs Officers, Clinical Risk-Benefit Groups, Local Medicines Authorities, CRO and Consultants providing QPPV Services, Pharma Industry Heads, Directors and Managers OF:
Special offer: Discounted travel with Lufthansa Group Airlines
Lufthansa Group Partner Airlines offer a comprehensive global route network linking major cities around the world. We offer special prices and conditions to participants, visitors, exhibitors, invited guests as well as employees of the Contracting partner and their travel companions. To make a reservation, please click on www.lufthansa.com/event-booking_en and enter the access code HUZJMSD in the “Access to Your Special Lufthansa Offer” area. This will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available. NOTE: Pop-ups must be enabled otherwise the booking platform window will not open. These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to email@example.com and providing the access code as a reference.
You can always register without a name using the TBA [To Be Announced] option. Please indicate TBA instead of the delegate name and 2 weeks prior to the event you are able to send the delegate name/s to booking[at]glceurope.com
While we are not happy to see you cancel your registration, we understand that “life happens” and other obligations come up. Our refund schedule is as follows: The client has the right to cancel his/her registration in the event. There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax. If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
In general no VAT is applied based on the Hungarian VAT law with the exception of individual payment [when you would like to pay from your own budget and not from the company’s budget] and for Hungarian companies where 27% VAT is applicable which is refundable at the end of the company’s fiscal year.
Our hospitality partners usually have options available for parking places, however it can change from event to event. If you would like to receive more information on parking please e-mail our colleague susanna.juhasz[at]glceurope.com.
We provide a conference documentation pack which includes: conference agenda, notes pages and attendee information. Soft copies of some of the presentation are available on USB-flash-drives for each delegate. You may bring your laptop, tablet or other mobile device so you are able to review the presentations while they are being presented. Free Wi-Fi will be provided and outlets will be available for recharging computers, mobile devices and phones. We highly recommend you to bring along your business cards and a desire to learn from some of the industry’s leading experts.
Get the timing right. Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture.
Make a case for yourself When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points: 1. Start by stating your accomplishments 2. Show that you’re ready for more responsibility and eager to learn 3. Describe: a) How this event will increase your productivity? b) How you will need less supervision c) How you can bring back the knowledge to the company 4. Follow up
You might find free to attend events which are usually organized by a solution/service provider within the industry. Unlike at free to attend events, on a paid event you will find more diverse industry knowledge rather than presentations related to services or solutions.
In case you cannot attend for both days, you can always attend for just 1 day of the event. In this case we will send you all presentations of the 2 days. The participation fee is 70% of the original investment. In case you would like to attend the event for just 1 day please contact us on booking[at]glceurope.com
We understand that not all senior-level professionals might be available on the dates. As the event is an annual event, most of the attendees try to postpone their engagements or send a small group from their teams to benefit from the conference.
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