ONLINE-SEMINAR

Regulatory Affairs and Market Entry in the MENA Region

Marketing Authorisation (MA) in Saudi Arabia, the UAE, Jordan, Oman, Lebanon, Egypt, Iran and the Maghreb

TOPICS YOUR SPEAKERS • Marketing authorisation Ala'a Saleem in the GCC states Science Forum (SIPS), Amman, JORDAN Deputy General Director "Technical Affairs" • eCTD necessities and eSubmission Dr Mohammed Saleem Boehmert & Boehmert, Representation Office Middle East and North Africa, JORDAN • The registration process General Director of SIPS (Science Forum for and maintenance Research & Consultancy). Dr Saleem has served as head of the IPR Committee & also as a member of • Current emergency legislation the technical review board on herbal medicine & (COVID-19) natural products at the Jordan FDA, as well as head of the LES-AC "Life Science Committee".

• Country by country Dr Makram Nehme information guaranteed PAREXEL International Ltd. Jdeide - Bouchrieh, Metn, LEBANON Regulatory Independent Consultant, Regulatory Affairs Manager - MENA

16 - 17 NOVEMBER 2020 ONLINE IN YOUR OFFICE / YOUR HOMEOFFICE Regulatory Affairs and Market Entry in the MENA Region

Aims and objectives YOUR SPEAKERS This online seminar informs you about the Ala'a Saleem regulatory framework and current Science Forum (SIPS), Amman, JORDAN legislation in the entire MENA region. Dr Mohammed Saleem It will make you aware of your regulatory duties in entering the markets of Saudi Boehmert & Boehmert, Representation Office Middle East and North Africa, JORDAN Arabia, the United Arab Emirates (UAE), Jordan, Oman, Lebanon, Egypt, Iran and the Dr Makram Nehme Maghreb, and maintaining your products in PAREXEL International Ltd. these markets. Local experts will not only Jdeide - Bouchrieh, Metn, LEBANON focus on procedures, but also address dossier requirements (including the eCTD) and other national market peculiarities. Your benefit • Three local experts share their Who should attend? regulatory and business development This online seminar will be of benefit to all expertise with you those working in the pharmaceutical • Dossier and procedural know-how in a industry, particularly in regulatory affairs single seminar and business development, who are interested in marketing pharmaceuticals in • Detailed information, country by country the MENA region. • Online learning format for your safety

This is how online seminars are working Booking option: e-Learning • The online seminars are live and If you would like to know the general interactive. regulatory affairs principles outside the ICH • They are held and controlled directly by region, we recommend our "e-Learning: our speakers. Marketing Authorisation Outside the ICH Region" • You may take part in the seminar from anywhere using your end device. This e-learning will show you how to • You will see the presentation and listen categorise the various regions in terms of to our speaker's lecture using Internet regulatory requirements. telephony (VoIP) or even a normal telephone connection. Please search for webcode 2012221 on • And you can also ask questions live and www.forum-institut.com http://www.forum- institut.com directly interact with the speakers. Your programme

Day one from 09:00 - 16:00 Day two from 09:00 - 14:00 Market entry in the Middle East MA in the Maghreb: Morocco, Tunisia Dr Mohammed Saleem and Algeria • Understanding the regulatory system: Dr Makram Nehme scientific offices, agents and • Marketing authorisation procedure and distributors requirements • eCTD and eSubmission regional • Important changes to the regulatory requirements requirements • Current emergency legislation due to • Authorised representative: setup and the coronavirus pandemic and its implications impact on regulatory affairs • Required documents, the registration process and maintenance Marketing authorisation (MA) in the • Variations and renewals GCC states Ala'a Saleem Regulatory affairs in Egypt • Central vs national marketing Dr Makram Nehme authorisation in the individual countries • Marketing authorisation procedure and • Central registration - regulatory requirements prerequisites, electronic submission of • Authorised representative dossiers and marketing authorisation maintenance • Required documents, the registration process and maintenance MA in Saudi Arabia and the UAE Ala'a Saleem MA in Iran Dr Makram Nehme • Marketing authorisation procedure and requirements • Regulatory framework in Iran • eCTD requirements and eSubmission • Company and product registration via a portal - capabilities of local • Marketing authorisation and partners in the e-system maintenance

MA in Jordan, Oman and Lebanon Ala'a Saleem • Market peculiarities • Marketing authorisation procedure and requirements • eCTD requirements • Post-approval activities Regulatory Affairs and Market Entry in the MENA Region

REGISTRATION UNDER [email protected] Tel. +49 6221 500-500 www.forum-institut.com Fax +49 6221 500-555 Webcode 2011232

REGISTRATION FORM Yes, I will attend Date and venue Regulatory Affairs and Market Entry in the MENA 16 - 17 November 2020 Region (Webcode 2011232) Online in your office / your homeoffice e-Learning Marketing Authorisation Outside the Day one: 09:00 - 16:00 ICH Region (Information and programme on our Day two: 09:00 - 14:00 website with the webcode 2012221) Yes, I agree that FORUM Institut may inform me about events by: □ email; and/or □ telephone. Fee seminar: I may withdraw my consent at any time. € 1,290.00 (+ German VAT) The fee includes course documentation including free download) as well a certificate. You will receive Name an invoice as well as confirmation.

Position, department

Company Fee e-learning: € 290.00 (+ German VAT) - e-Learning Street Marketing Authorisation Outside the ICH Region This fee is only valid in combination with the above mentioned seminar. Post code, city, country

Tel. no./Fax no. Our quality promise We are proud of having passed the PharmaTrain E-mail Federation quality audit with excellence. We are now a recognised ‘PharmaTrain Centre’. Contact person at office FI8417/0/0/0/0/0

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CANCELLATION POLICY YOUR CONTACT Our general terms and conditions (as of 1 January 2016) apply and are available upon request. We can Dr. Henriette Wolf-Klein send them to you at any time. Alternatively, you can Head of Department access them online at www.forum-institut.com/t&c Tel. +49 6221 500-680 [email protected]

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