RA Speakers 2022 Archives - Page 2 of 7 - Pharma Regulatory Africa Summit

DR. KATE KIKULE

September 1, 2022/in RA Speakers 2022/by pharmaadmin

Kate Kikule is the Principal Technical Advisor for the pharmaceutical regulatory systems portfolio under the Medicines, Technologies and Pharmaceutical Services (MTaPS) initiative of the Medicines Sciences for Health (MSH), with expertise in regulation of medicines and health technologies. Kikule supports country programs by providing technical assistance to strengthen medicine regulatory functions, including medicine registration, regulatory inspections, licensing of premises, market surveillance, and pharmacovigilance. She also provides technical guidance for the development and implementation of policies, regulations, guidelines, and tools for strong and effective pharmaceutical regulatory systems. She is an experienced public health professional and pharmacist with more 20 years of experience in medicine regulation in emerging and low- and middle-income countries across Africa, Asia, and Europe. Kikule holds a Bachelor of Pharmacy (Hons) from the University of Dar-es- Salaam, United Republic of Tanzania, and an MPH specializing in health economics from the University of Capetown, South Africa.

DR. SAMEH JELLALI

September 1, 2022/in RA Speakers 2022/by pharmaadmin

Depuis 2017 : Pharmacienne de santé publique à la Direction de la Pharmacie et du Médicament (DPM) chargée de :

La réception et l’évaluation des dossiers d’Autorisation de Mise sur le Marché (AMM)
La participation aux travaux des commissions spécialisées (Neurologie, Psychiatrie, Ophtalmologie, Dermatologie, …) et la Commission d’Achat des Médicaments (CAM) à la Pharmacie Centrale de Tunisie (PCT).
La validation des bons de commandes fermes (ATU)
Suivi de la pénurie des médicaments

2013-2017: Pharmacienne assistante en officine privée.
Octobre 2012-Septembre 2017: Pharmacienne formatrice à l’Institut Tunisien de Santé

2012: Préparation de thèse de doctorat en Pharmacie (Recherche à l’Institut Pasteur de Tunis : Laboratoire Parasitologie et Immunologie)

Septembre -Novembre 2011 : Stage officinal au sein d’une Officine privée « Pharmacie Hattab Naouar Nouvelle Médina»: Dispensation de médicaments, Conseils, Préparations officinales, Préparations magistrales, Gestion officinale…

Décembre- Février 2012 : Stage en biologie clinique au sein de laboratoire de Biochimie et de Toxicologie de Centre Hospitalo-Universitaire la Rabta Tunis
Septembre 2009 – Février 2010 :

Stage de 1 mois en Pharmacie hospitalière à l’EPS Aziza Othmana Tunis: pharmacie interne, pharmacie externe, préparatoire, dépôt des médicaments et dépôt des dispositifs médicaux.
Stage de 5 mois d’Initiation à la Pharmacie clinique au Centre Hospitalo- à l’EPS Aziza Othmana Tunis: Service hématologie.

Juin- Juillet 2005 :

Stage d’Initiation aux soins infirmiers au service de maternité/Gynécologie de l’Hôpital Régional de
Stage au sein de la pharmacie de l’Hôpital Régional de

Juin 2004 : Stage d’Initiation à la pratique officinale au sein d’une Officine privée « Pharmacie Hattab Naouar Nouvelle Médina»: Dispensation de médicaments, Conseils, Préparations officinales, Préparations magistrales, Gestion officinale…

COMPETENCES

Maîtrise des Préparations hospitalières et officinales.
Maîtrise des Préparations Magistrales.
Maîtrise des logiciels de bureautique : Word, Excel, Power Point …
Permis de conduire

LANGUES

Français : lu, écrit et parlé
Anglais : lu, écrit et parlé
Arabe : langue maternelle
Allemand : lu et écrit

DIVERS

SPORT
LECTURE
VOYAGE

MS. PATRICIA SALAMI, Pharm.D

September 1, 2022/in RA Speakers 2022/by pharmaadmin

Patricia is a Pharm D. Grad. from ‘Saint Joseph University’, Beirut, Lebanon with 20 years of experience in the corporate pharma world (Novartis, Wyeth, Pfizer, Merck), mainly in the regulatory affairs arena.

She is currently heading the regulatory affairs of the healthcare business of Merck in the MEAR region: Middle East, Africa, Turkey, Russia & CIS countries; handling a wide & diverse team of RA professionals who are well engaged and acting as external pioneers in the industry via various trade associations i.e., IFPMA-ARN, IPASA, PhRMA, EFPIA: MERN, Russia-CIS & Turkey.

Since the beginning of her RA Career, Patricia was keen on enabling access of medicines and therapeutic solutions to patients around the world. Hence, she has been a highly active member in the industry via IFPMA/EFPIA/PhRMA associations and have contributed to multiple key events like pre-ICDRA, ICRDA, DIA MERC, Access to Innovation Webinars amongst many others, partnering with multiple Authorities in the MEA region.

Since March 2021, Patricia has been acting as the Chair of the PhRMA MEA RA Group; enabling, with the support of her seasoned esteemed peers, the design and implementation of multiple capabilities’ building programs for key Authorities in the MEA region like KSA, Algeria, Egypt & South Africa, which have been translated into enhanced and re-shaped policies & regulations.

Patricia’s belief is in passion to make great things happen with her motto being: “Regulate for a brighter future. Partner for earlier & better access”.

MS. MARGARETH NDOMONDO-SIGONDA, PhD.

September 1, 2022/in RA Speakers 2022/by pharmaadmin

Margareth Ndomondo-Sigonda, works for AUDA-NEPAD as the Head of Programme. She is responsible for providing technical lead and strategic oversight on health and pharmaceutical programs such as the African Medicines Regulatory Harmonization (AMRH) Initiative, the establishment of African Medicines Agency as a specialized agency of the African Union (AU), and promotion of local production of pharmaceuticals in Africa. She currently leads the regulatory workstream of the AU Partnerships for African Vaccines Manufacturing (PAVM) Framework.

She previously served as Chief Pharmacist and Registrar of Pharmacy Board of Tanzania (1998-2003) and as the first Director General of the Tanzania Food and Drugs Authority (2003-2010).

She holds a PhD in Pharmacology from the University of the Witwatersrand, Johannesburg, South Africa.

MS. NEVENA MILETIC

September 1, 2022/in RA Speakers 2022/by pharmaadmin

Nevena Miletic is a Regulatory and Policy professional, passionate about bringing innovative therapeutic solutions to patients in need around the world.

She is a pharmacist, with postgraduate studies in Pharmacoeconomics, regulatory affairs and quality assurance, and a certified QP, with almost twenty years of experience in pharmaceutical industry.

Currently she works in the Global Regulatory Policy group in F. Hoffmann-La Roche, Switzerland, and for the last six years, she is chairing IFPMA Africa Regulatory Network and IFPMA CPP Network.

She is also a member of research-based pharmaceutical companies associations and boards (IFPMA Regulatory Science Committee, IFPMA Africa Engagement Committee, DIA Middle East & Africa Advisory Board, EFPIA ERAO, IATF etc.), involved in numerous meetings, workshops and projects with regulators, cross-industry and public-private collaborative platforms (e.g. Pre-ICDRA, ICDRA, SCoMRA, IMI/IHI etc.).

Ms. Miletic is strong advocate for regulatory convergence and harmonization, as well as for modernization of regulatory frameworks to enable innovative approaches in drug development and review.

AGNES KEMIGISHA

September 1, 2022/in RA Speakers 2022/by pharmaadmin

MS. HADEER SAYED

September 1, 2022/in RA Speakers 2022/by pharmaadmin

My current title is EMEA RA Lifecycle manager at Janssen. I am handling lifecycle management activities for the Pharma portfolio for countries in the Non-European Economic area region (includes Africa).

I have 10 years of Regulatory experience in different Regional/Global roles from 4 different pharma companies like Pfizer, GSK, Amgen and Janssen. I keep it brief, but please let me know if you want more details.